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ABSORB FIRST Registry

This study is currently recruiting participants.
Verified February 2013 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01759290
First received: December 14, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

ABSORB FIRST is a registry designed to:

  • Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily PCI practice per Instructions for Use (IFU, on-label use).
  • 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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Clinical Device success (lesion based analysis) [ Time Frame: From start of index procedure to end of index procedure. ] [ Designated as safety issue: No ]

    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.

    Time Frame: On a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

    This study has no primary endpoint. All endpoints are equivalent.


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

    Achievement of a final in-scaffold diameter stenosis of < 50% by online 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.

    This study has no primary endpoint. All endpoints are equivalent.



Other Outcome Measures:
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    subset of patients

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, all (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization, all (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, all (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, all (TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, all (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization, all (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, all (TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, all (TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients

  • Scaffold/Stent Thrombosis Timing (acute) [ Time Frame: within 24 hours of index procedure ] [ Designated as safety issue: Yes ]
    Definite, Probable

  • Scaffold/Stent Thrombosis Timing (sub-acute) [ Time Frame: >24 hours to 30 days ] [ Designated as safety issue: Yes ]
    Definite, Probable

  • Scaffold/Stent Thrombosis Timing (late) [ Time Frame: >30 days to 1 year ] [ Designated as safety issue: Yes ]
    Definite, Probable

  • Scaffold/Stent Thrombosis Timing (very late) [ Time Frame: >1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10000
Study Start Date: January 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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:

In the USA, Absorb BVS is currently in development at Abbott Vascular. Not available for sale.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759290

Contacts
Contact: Marie-Hélène Thèret-Bettiol, PhD +32 2 71-41586 mariehelene.theret@av.abbott.com

Locations
Belgium
Abbott Vascular International BVBA Recruiting
Brussels, Belgium, 0886.537.933
Contact: Marie-Hélène Thèret-Bettiol, Ph.D.     +32 2 71-41586     mariehelene.theret@av.abbott.com    
Sponsors and Collaborators
Abbott Vascular
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01759290     History of Changes
Other Study ID Numbers: 12-302
Study First Received: December 14, 2012
Last Updated: February 1, 2013
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 Occlusion
Coronary Stenosis
Coronary Restenosis
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013