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Completed

NCT Number: NCT01023789

ABSORB EXTEND Clinical Investigation

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Cardiovascular de Buenos Aires-ICBA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
  • Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
  • 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 treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (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).
  • Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
  • Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion criteria

  • Lesion(s) 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(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
  • Total occlusion (TIMI flow 0), prior to wire passing.
  • Target vessel(s) contains visible thrombus.
  • Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
  • Subject has received brachytherapy in any epicardial vessel (including side branches).

Treatment and study plan

ABSORB BVS

Device

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Primary outcomes

  1. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: ≤ 7 days post index procedure (In hospital)

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).

  2. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: 0 to 30 days

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.

  3. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: 0 to 180 days

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

  4. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: 0 to 1 year

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

Secondary outcomes

  1. Clinical Device Success

    Time frame: On day 0 (immediate post-index procedure)

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

  2. Clinical Procedure Success

    Time frame: On day 0 (immediate post-index procedure)

    Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% 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. In a dual lesion setting both lesions must meet clinical procedure success.

  3. Number of Participants With Cardiac Death

    Time frame: ≤ 7 days post index procedure (In-hospital )

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  4. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: ≤ 7 days post index procedure (In-hospital )

    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

  5. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    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.

  6. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    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.

  7. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

  8. Number of Participants With Cardiac Death

    Time frame: 0 to 30 days

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  9. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: 0 to 30 days

    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

  10. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 0 to 30 days

    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.

  11. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 0 to 30 days

    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.

  12. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: 0 to 30 days

  13. Number of Participants With Cardiac Death

    Time frame: 0 to 180 days

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  14. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: 0 to 180 days

    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

  15. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 0 to 180 days

    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.

  16. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 0 to 180 days

    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.

  17. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: 0 to 180 days

  18. Number of Participants With Cardiac Death

    Time frame: 0 to 1 year

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  19. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: 0 to 1 year

    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

  20. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 0 to 1 year

    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. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 0 to 1 year

    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.

  22. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: 0 to 1 year

  23. Number of Participants With Cardiac Death

    Time frame: 0 to 2 year

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  24. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: 0 to 2 year

    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

  25. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 0 to 2 year

    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.

  26. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 0 to 2 year

    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. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: 0 to 2 year

  28. Number of Participants With Cardiac Death

    Time frame: 0 to 3 years

    Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  29. Number of Participants With Myocardial Infarction (MI) - Per Protocol

    Time frame: 0 to 3 years

    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

  30. Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

    Time frame: 0 to 3 years

    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.

  31. Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 0 to 3 years

    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. Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)

    Time frame: 0 to 3 years

  33. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: ≤ 7 days post index procedure (In hospital)

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  34. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: 0 to 30 days

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  35. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: 0 to 180 days

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  36. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: 0 to 1 year

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  37. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: 0 to 2 years

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  38. Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)

    Time frame: 0 to 3 years

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.

  39. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: 0 to 2 years

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

  40. Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

    Time frame: 0 to 3 years

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

  41. Number of Participants With Scaffold Thrombosis (Early)

    Time frame: 0 to 30 days

    According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  42. Number of Participants With Scaffold Thrombosis

    Time frame: 0 to 180 days

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  43. Number of Participants With Scaffold Thrombosis (Late)

    Time frame: 31 - 365 days

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  44. Number of Participants With Scaffold Thrombosis

    Time frame: 0 to 1 year

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  45. Number of Participants With Scaffold Thrombosis (Very Late)

    Time frame: 366 days to 2 years

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  46. Number of Participants With Scaffold Thrombosis

    Time frame: 0 to 2 years

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  47. Number of Participants With Scaffold Thrombosis

    Time frame: 0 to 3 years

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  48. Area Stenosis (%)

    Time frame: 18 months

  49. Minimum Lumen Area

    Time frame: 18 months

  50. Mean Vessel Area

    Time frame: 18 months

  51. Minimum Vessel Area

    Time frame: 18 months

  52. Maximum Vessel Area

    Time frame: 18 months

  53. Mean Lumen Area

    Time frame: 18 months

  54. Maximum Lumen Area

    Time frame: 18 months

  55. Mean Plaque Area

    Time frame: 18 months

  56. Minimum Plaque Area

    Time frame: 18 months

  57. Maximum Plaque Area

    Time frame: 18 months

  58. Mean Reference Area

    Time frame: 18 months

  59. Calculated Minimum Lumen Diameter

    Time frame: 18 months

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

  60. Calculated Diameter Stenosis

    Time frame: 18 months

    The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Acronym: ABSORB EXTEND

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2009
Registry last updated
Feb 14, 2018

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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