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Completed

NCT Number: NCT01759290

ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:

* Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use). * To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s) * Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.

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Key information

Conditions

Chronic Total Occlusion of Coronary Artery Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Restenosis Coronary Artery Stenosis Coronary Disease Coronary Occlusion Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Vascular International BVBA

Brussels, 0886.537.933, Belgium

About this study

the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).

The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
  • Patient must be at least 18 years of age at the time of signing the Informed Consent Form
  • Patient is to be treated for de novo lesions located in previously untreated vessels.
  • Patient must agree to undergo all required follow-up visits and data collection.

Exclusion criteria

  • The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
  • Inability to obtain a signed informed consent from potential patient.
  • Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).

Treatment and study plan

Absorb Bioresorbable Vascular Scaffold

Device

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Primary outcomes

  1. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

    Time frame: 0 to 407 days

    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

Secondary outcomes

  1. Acute Success: Clinical Device Success (Lesion Level Analysis)

    Time frame: < or = 1 day

    Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.

  2. Acute Success: Clinical Procedure Success (Per Subject Analysis)

    Time frame: During the hospital stay with a maximum of 3 days post index procedure

    Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.

  3. Acute Scaffold Thrombosis

    Time frame: <1 day

  4. Subacute ScaffoldThrombosis

    Time frame: 1 to 30 days

  5. Late Scaffold Thrombosis

    Time frame: 31 to 365 Days

  6. All Death, All MI, All Revascularization (DMR)

    Time frame: 0 to 7 days (In-hospital)

  7. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

    Time frame: 0 to 7 days (In-hospital)

    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  8. Major Adverse Cardiac Event (MACE)

    Time frame: 0 to 7 days (In-hospital)

    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  9. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

    Time frame: 0 to 7 days (In-hospital)

    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  10. Cardiac Death/All MI

    Time frame: 0 to 7 days (In-hospital)

  11. All Death/All MI

    Time frame: 0 to 7 days (In-hospital)

  12. All Death, All MI, All Revascularization (DMR)

    Time frame: 0 to 37 days

  13. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

    Time frame: 0 to 37 days

    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  14. Major Adverse Cardiac Event (MACE)

    Time frame: 0 - 37 Days

    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  15. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

    Time frame: 0 to 37 Days

    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  16. Cardiac Death/All MI

    Time frame: 0 to 37 days

  17. All Death/All MI

    Time frame: 0 to 37 days

  18. All Death, All MI, All Revascularization (DMR)

    Time frame: 0 to 180 days

  19. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

    Time frame: 0 to 180 days

    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  20. Major Adverse Cardiac Event (MACE)

    Time frame: 0 to 180 Days

    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  21. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))

    Time frame: 0 to 180 Days

    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  22. Cardiac Death/All MI

    Time frame: 0 to 180 days

  23. All Death/All MI

    Time frame: 0 to 180 days

  24. All Death, All MI, All Revascularization (DMR)

    Time frame: 0 to 407 days

  25. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)

    Time frame: 0 to 407 days

    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  26. Major Adverse Cardiac Event (MACE)

    Time frame: 0 to 407 Days

    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).

  27. Cardiac Death/All MI

    Time frame: 0 to 407 days

  28. All Death/All MI

    Time frame: 0 to 407 days

  29. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Safety Component (non-hierarchical) endpoints.

  30. All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Safety Component (non-hierarchical) endpoints.

  31. Target Lesion Revascularization (TLR): All TLR

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  32. Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  33. Target Vessel Revascularization (TVR): All TVR

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  34. Target Vessel Revascularization : Ischemic-driven (ID-TVR)

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  35. All Revascularization

    Time frame: 0 to 7 days (In-hospital)

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  36. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 0 to 37 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  37. All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).

    Time frame: 0 to 37 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  38. Target Lesion Revascularization (TLR): All TLR

    Time frame: 0 to 37 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  39. Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

    Time frame: 0 to 37 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  40. Target Vessel Revascularization (TVR): All TVR

    Time frame: 0 to 37 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  41. Target Vessel Revascularization : Ischemic-driven (ID-TVR)

    Time frame: 0 to 37 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  42. All Revascularization

    Time frame: 0 to 37 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  43. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 0 to 180 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  44. All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).

    Time frame: 0 to 180 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  45. Target Lesion Revascularization (TLR): All TLR

    Time frame: 0 to 180 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  46. Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

    Time frame: 0 to 180 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  47. Target Vessel Revascularization (TVR): All TVR

    Time frame: 0 to 180 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  48. Target Vessel Revascularization : Ischemic-driven (ID-TVR)

    Time frame: 0 to 180 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  49. All Revascularization

    Time frame: 0 to 180 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  50. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 0 to 407 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  51. All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).

    Time frame: 0 to 407 days

    This is one of the Safety Component (non-hierarchical) endpoints.

  52. Target Lesion Revascularization (TLR): All TLR

    Time frame: 0 to 407 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  53. Target Lesion Revascularization : Ischemia-Driven (ID-TLR)

    Time frame: 0 to 407 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  54. Target Vessel Revascularization (TVR): All TVR

    Time frame: 0 to 407 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  55. Target Vessel Revascularization : Ischemic-driven (ID-TVR)

    Time frame: 0 to 407 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

  56. All Revascularization

    Time frame: 0 to 407 days

    This is one of the Efficacy Component (non-hierarchical) endpoints.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 3, 2013
Registry last updated
Oct 19, 2016

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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