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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01759290
First received: December 14, 2012
Last updated: August 26, 2016
Last verified: August 2016
  Purpose

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.

Condition Intervention
Chronic Total Occlusion of Coronary Artery
Coronary Occlusion
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis
Coronary Disease
Coronary Restenosis
Device: Absorb Bioresorbable Vascular Scaffold

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official 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).

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Acute Success: Clinical Device Success (Lesion Level Analysis) [ Time Frame: < or = 1 day ] [ Designated as safety issue: No ]
    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.

  • Acute Success: Clinical Procedure Success (Per Subject Analysis) [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure ] [ Designated as safety issue: No ]
    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.

  • Acute Scaffold Thrombosis [ Time Frame: <1 day ] [ Designated as safety issue: Yes ]
  • Subacute ScaffoldThrombosis [ Time Frame: 1 to 30 days ] [ Designated as safety issue: Yes ]
  • Late Scaffold Thrombosis [ Time Frame: 31 to 365 Days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    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).

  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/All MI [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    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).

  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 - 37 Days ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 37 Days ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/All MI [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    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).

  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 180 Days ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 180 Days ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/All MI [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    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).

  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 407 Days ] [ Designated as safety issue: Yes ]
    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).

  • Cardiac Death/All MI [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • 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) ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • All Revascularization [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • All Revascularization [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • All Revascularization [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.

  • All Revascularization [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.


Enrollment: 1800
Study Start Date: January 2013
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Device: Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759290

Locations
Belgium
Abbott Vascular International BVBA
Brussels, Belgium, 0886.537.933
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Ashok Seth, MD Fortis Escorts Heart Institute, New Delhi
Principal Investigator: Eric Eeckhout, MD, PhD Centre Hospitalier Universitaire Vaudois
Study Director: Peter Staehr, MD Abbott Vascular
Study Director: Vivian Mao, MD, MPH Clinical Science
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01759290     History of Changes
Other Study ID Numbers: 12-302 
Study First Received: December 14, 2012
Results First Received: August 26, 2016
Last Updated: August 26, 2016
Health Authority: Belgium: Institutional Review Board

Keywords provided by Abbott Vascular:
Angioplasty
Bioabsorbable
Bioresorbable
BVS
Coronary Artery Endothelial Responsiveness
Coronary Scaffold
Coronary Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016