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OpenTrials
Completed

NCT Number: NCT00856856

ABSORB Clinical Investigation, Cohort B

The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.

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Key information

Conditions

Coronary Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General inclusion criteria

  • Patient must be at least 18 years of age.
  • Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
  • Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure

Angiographic Inclusion Criteria

  • Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
  • Target lesion(s) must measure ≤ 14 mm in length by visual estimation
  • Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
  • If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches
  • If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria
  • Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
  • Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure

General Exclusion Criteria

  • Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
  • The patient is currently experiencing clinical symptoms consistent with AMI
  • Patient has current unstable arrhythmias
  • Patient has a known left ventricular ejection fraction (LVEF) < 30%
  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  • Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
  • Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Patient has had a significant GI or urinary bleed within the past six months
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  • Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
  • Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
  • Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
  • Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

  • Target lesion(s) meets any of the following criteria:
  • Aorto-ostial location (within 3 mm)
  • Left main location
  • Located within 2 mm of the origin of the LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
  • Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
  • Total occlusion (TIMI flow 0), prior to wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation (≥ 90%) proximal to or within the lesion
  • Heavy calcification
  • Restenotic from previous intervention
  • The target vessel contains visible thrombus
  • Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
  • Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Treatment and study plan

Bioabsorbable Everolimus Eluting Coronary Stent

Device

Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Primary outcomes

  1. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 30 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  2. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 1 year

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  3. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days

    Time frame: 180 days

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  4. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year

    Time frame: 1 year

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Secondary outcomes

  1. Clinical Device Success (Per Lesion)

    Time frame: On day 0 (the day of procedure)

    Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.

  2. Clinical Procedure Success (Per Patient)

    Time frame: On day 0 (the day of procedure)

    Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.

  3. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 180 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  4. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 270 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  5. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 2 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  6. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 3 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  7. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 4 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  8. Hierarchical Major Adverse Cardiac Event (MACE)

    Time frame: 5 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

  9. Hierarchical Target Vessel Failure (TVF)

    Time frame: 30 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  10. Hierarchical Target Vessel Failure (TVF)

    Time frame: 180 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  11. Hierarchical Target Vessel Failure (TVF)

    Time frame: 270 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  12. Hierarchical Target Vessel Failure (TVF)

    Time frame: 1 year

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  13. Hierarchical Target Vessel Failure (TVF)

    Time frame: 2 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  14. Hierarchical Target Vessel Failure (TVF)

    Time frame: 3 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  15. Hierarchical Target Vessel Failure (TVF)

    Time frame: 4 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  16. Hierarchical Target Vessel Failure (TVF)

    Time frame: 5 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  17. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 30 days

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  18. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 180 days

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  19. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 270 days

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  20. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 1 year

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  21. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 2 years

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  22. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 3 years

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  23. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 4 years

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  24. Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 5 years

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  25. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 30 days

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  26. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 180 days

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  27. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 270 days

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  28. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 1 year

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  29. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 2 years

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  30. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 3 years

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  31. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 4 years

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  32. Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 5 years

    ID-TVR is the revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

  33. Cardiac Death

    Time frame: 30 days

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  34. Cardiac Death

    Time frame: 1 year

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  35. Cardiac Death

    Time frame: 2 years

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  36. Cardiac Death

    Time frame: 3 years

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  37. Cardiac Death

    Time frame: 4 years

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  38. Cardiac Death

    Time frame: 5 years

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded.

    (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

  39. Myocardial Infarction

    Time frame: 30 days

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  40. Myocardial Infarction

    Time frame: 1 year

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  41. Myocardial Infarction

    Time frame: 2 years

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  42. Myocardial Infarction

    Time frame: 3 years

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  43. Myocardial Infarction

    Time frame: 4 years

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  44. Myocardial Infarction

    Time frame: 5 years

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  45. Scaffold Thrombosis

    Time frame: 30 days

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  46. Scaffold Thrombosis

    Time frame: 1 year

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  47. Scaffold Thrombosis

    Time frame: 2 years

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  48. Scaffold Thrombosis

    Time frame: 3 years

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  49. Scaffold Thrombosis

    Time frame: 4 years

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  50. Scaffold Thrombosis

    Time frame: 5 years

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:

    • Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
    • In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)

    Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

  51. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years

    Time frame: 2 years

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  52. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years

    Time frame: 3 years

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  53. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years

    Time frame: 5 years

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

  54. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days

    Time frame: 180 days

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

  55. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year

    Time frame: 1 year

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

  56. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years

    Time frame: 2 years

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

  57. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years

    Time frame: 3 years

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

  58. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years

    Time frame: 5 years

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

  59. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days

    Time frame: 180 days

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

  60. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year

    Time frame: 1 year

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

  61. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years

    Time frame: 2 years

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

  62. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years

    Time frame: 3 years

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

  63. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years

    Time frame: 5 years

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

  64. In-scaffold Angiographic Binary Restenosis (ABR)

    Time frame: 180 days

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  65. In-scaffold Angiographic Binary Restenosis (ABR)

    Time frame: 1 year

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  66. In-scaffold Angiographic Binary Restenosis (ABR)

    Time frame: 2 years

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  67. In-scaffold Angiographic Binary Restenosis (ABR)

    Time frame: 3 years

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  68. In-scaffold Angiographic Binary Restenosis (ABR)

    Time frame: 5 years

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

  69. Persisting Dissection

    Time frame: 180 days

    Dissection at follow-up that was present post-procedure.

  70. Persisting Dissection

    Time frame: 1 year

    Dissection at follow-up that was present post-procedure.

  71. Persisting Dissection

    Time frame: 2 years

    Dissection at follow-up that was present post-procedure.

  72. Persisting Dissection

    Time frame: 3 years

    Dissection at follow-up that was present post-procedure.

  73. Persisting Dissection

    Time frame: 5 years

    Dissection at follow-up that was present post-procedure.

  74. In-scaffold Percent Diameter Stenosis (%DS)

    Time frame: 180 days

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  75. In-scaffold Percent Diameter Stenosis (%DS)

    Time frame: 1 year

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  76. In-scaffold Percent Diameter Stenosis (%DS)

    Time frame: 2 years

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  77. In-scaffold Percent Diameter Stenosis (%DS)

    Time frame: 3 years

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  78. In-scaffold Percent Diameter Stenosis (%DS)

    Time frame: 5 years

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

  79. Aneurysm

    Time frame: 180 days

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

  80. Aneurysm

    Time frame: 1 year

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

  81. Aneurysm

    Time frame: 2 years

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

  82. Aneurysm

    Time frame: 3 years

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

  83. Aneurysm

    Time frame: 5 years

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

  84. Thrombus

    Time frame: 180 days

  85. Thrombus

    Time frame: 1 year

  86. Thrombus

    Time frame: 2 years

  87. Thrombus

    Time frame: 3 years

  88. Thrombus

    Time frame: 5 years

  89. Vasomotion Analysis: In-scaffold Mean Luminal Diameter

    Time frame: 5 years

    Vasomotion function was assessed in reaction to nitrate administration.

  90. Volume Obstruction (VO)

    Time frame: 180 days

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  91. Volume Obstruction (VO)

    Time frame: 1 year

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  92. Volume Obstruction (VO)

    Time frame: 2 year

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  93. Volume Obstruction (VO)

    Time frame: 3 year

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

  94. Persisting Incomplete Apposition

    Time frame: 180 days

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  95. Persisting Incomplete Apposition

    Time frame: 1 year

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  96. Persisting Incomplete Apposition

    Time frame: 2 year

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  97. Persisting Incomplete Apposition

    Time frame: 3 year

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  98. Late Incomplete Apposition

    Time frame: 180 days

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  99. Late Incomplete Apposition

    Time frame: 1 year

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  100. Late Incomplete Apposition

    Time frame: 2 year

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

  101. Late Incomplete Apposition

    Time frame: 3 year

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.

    Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Other outcomes

  1. Mean Reference Area

    Time frame: 1 year

  2. Mean Reference Area

    Time frame: 2 years

  3. Mean Reference Area

    Time frame: 3 years

  4. Mean Reference Area

    Time frame: 5 years

  5. Mean Luminal Area

    Time frame: 1 year

  6. Mean Luminal Area

    Time frame: 2 years

  7. Mean Luminal Area

    Time frame: 3 years

  8. Mean Luminal Area

    Time frame: 5 years

  9. Minimum Luminal Area

    Time frame: 1 year

  10. Minimum Luminal Area

    Time frame: 2 years

  11. Minimum Luminal Area

    Time frame: 3 years

  12. Minimum Luminal Area

    Time frame: 5 years

  13. Mean Stent Area

    Time frame: 1 year

  14. Mean Scaffold Area

    Time frame: 2 years

  15. Mean Scaffold Area

    Time frame: 3 years

  16. Minimum Stent Area

    Time frame: 1 year

  17. Minimum Scaffold Area

    Time frame: 2 year

  18. Minimum Scaffold Area

    Time frame: 3 years

  19. Luminal Volume

    Time frame: 1 year

  20. Luminal Volume

    Time frame: 2 years

  21. Luminal Volume

    Time frame: 3 years

  22. Luminal Volume

    Time frame: 5 years

  23. Stent Volume

    Time frame: 1 year

  24. Scaffold Volume

    Time frame: 2 years

  25. Scaffold Volume

    Time frame: 3 years

  26. Mean Luminal Diameter

    Time frame: 1 year

  27. Mean Luminal Diameter

    Time frame: 2 years

  28. Mean Luminal Diameter

    Time frame: 3 years

  29. Mean Luminal Diameter

    Time frame: 5 years

    It is measured during QCA by the Angiographic Core Lab.

  30. Minimum Luminal Diameter (MLD)

    Time frame: 1 year

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

  31. Minimum Luminal Diameter

    Time frame: 2 years

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

  32. Minimum Luminal Diameter

    Time frame: 3 years

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

  33. Minimum Luminal Diameter

    Time frame: 5 years

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

  34. Mean Stent Diameter

    Time frame: 1 year

  35. Mean Scaffold Diameter

    Time frame: 2 years

  36. Mean Scaffold Diameter

    Time frame: 3 years

  37. Minimum Stent Diameter

    Time frame: 1 year

  38. Minimum Scaffold Diameter

    Time frame: 2 years

  39. Minimum Scaffold Diameter

    Time frame: 3 years

  40. Strut Volume

    Time frame: 1 year

  41. Strut Volume

    Time frame: 2 years

  42. Strut Volume

    Time frame: 3 years

  43. Number of Struts Per BVS

    Time frame: 1 year

  44. Number of Struts Per BVS

    Time frame: 2 years

  45. Number of Struts Per BVS

    Time frame: 3 years

  46. Number of Struts Per BVS

    Time frame: 5 years

  47. % of Covered Struts (150 µm)

    Time frame: 1 year

  48. % of Acutely Covered Struts

    Time frame: 2 years

  49. % of Acutely Covered Struts

    Time frame: 3 years

  50. % of Uncovered Struts (150 µm)

    Time frame: 1 year

  51. % of Uncovered Struts (150 µm)

    Time frame: 2 years

  52. % of Uncovered Struts (150 µm)

    Time frame: 3 years

  53. Number of Struts in Side Branch

    Time frame: 1 year

  54. Number of Struts in Side Branch

    Time frame: 2 years

  55. Number of Struts in Side Branch

    Time frame: 3 years

  56. Number of Struts in Side Branch

    Time frame: 5 years

  57. Tissue Coverage Area Classical

    Time frame: 1 year

  58. Tissue Coverage Area BVS (Neointimal Area)

    Time frame: 1 year

  59. Tissue Coverage Volume Classical

    Time frame: 1 year

  60. Tissue Coverage Volume BVS

    Time frame: 1 year

  61. Tissue Coverage Obstruction Volume Classical

    Time frame: 1 year

  62. Tissue Coverage Obstruction Volume BVS

    Time frame: 1 year

  63. Tissue Coverage Area Classical

    Time frame: 2 years

  64. Tissue Coverage Area BVS (Neointimal Area)

    Time frame: 2 years

  65. Tissue Coverage Volume Classical

    Time frame: 2 years

  66. Tissue Coverage Volume BVS

    Time frame: 2 years

  67. Tissue Coverage Obstruction Volume Classical

    Time frame: 2 years

  68. Tissue Coverage Obstruction Volume BVS

    Time frame: 2 years

  69. Tissue Coverage Area Classical

    Time frame: 3 years

  70. Tissue Coverage Area BVS (Neointimal Area)

    Time frame: 3 years

  71. Tissue Coverage Volume Classical

    Time frame: 3 years

  72. Tissue Coverage Volume BVS

    Time frame: 3 years

  73. Tissue Coverage Obstruction Volume Classical

    Time frame: 3 years

  74. Tissue Coverage Obstruction Volume BVS

    Time frame: 3 years

  75. Mean Flow Area

    Time frame: 1 year

  76. Minimum Flow Area

    Time frame: 1 year

  77. Mean Strut Core Area

    Time frame: 1 year

  78. Percent (%) Lumen Area Stenosis

    Time frame: 1 year

  79. Mean Flow Area

    Time frame: 2 years

  80. Minimum Flow Area

    Time frame: 2 years

  81. Mean Strut Core Area

    Time frame: 2 years

  82. Percent (%) Lumen Area Stenosis

    Time frame: 2 years

  83. Mean Flow Area

    Time frame: 3 years

  84. Minimum Flow Area

    Time frame: 3 years

  85. Mean Strut Core Area

    Time frame: 3 years

  86. Percent (%) Lumen Area Stenosis

    Time frame: 3 years

  87. Mean Flow Area

    Time frame: 5 years

  88. Minimum Flow Area

    Time frame: 5 years

  89. Percent (%) Lumen Area Stenosis

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

Acronym: ABSORB B

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Mar 6, 2009
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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