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

NCT01759290 | Completed Results

• 1 other identifier: 12-302
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Total Occlusion of Coronary Artery; Coronary Occlusion; Coronary Artery Disease; Coronary Artery Restenosis; Coronary Artery Stenosis; Coronary Disease; Coronary Restenosis

Keywords

Angioplasty; Bioabsorbable; Bioresorbable; BVS; Coronary Artery Endothelial Responsiveness; Coronary Scaffold; Coronary Stent

Outcome Measures

Primary Outcomes (1)

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

  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).

  0 to 407 days

Secondary Outcomes (56)

• Acute Success: Clinical Device Success (Lesion Level Analysis)

  < or = 1 day

• Acute Success: Clinical Procedure Success (Per Subject Analysis)

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

• Acute Scaffold Thrombosis

  <1 day

• Subacute ScaffoldThrombosis

  1 to 30 days

• Late Scaffold Thrombosis

  31 to 365 Days

Study Arms (1)

Absorb Bioresorbable Vascular Scaffold

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Device: Absorb Bioresorbable Vascular Scaffold

Interventions

Absorb Bioresorbable Vascular Scaffold DEVICE

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Absorb Bioresorbable Vascular Scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular International BVBA

Brussels, 0886.537.933, Belgium

Location

MeSH Terms

Conditions

Coronary Occlusion; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Kunal Sampat
• Organization: Abbott Vascular

kunal.sampat@av.abbott.com

408-845-0746

Study Officials

• Ashok Seth, MD

  Fortis Escorts Heart Institute, New Delhi

  PRINCIPAL INVESTIGATOR

• Eric Eeckhout, MD, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

• Peter Staehr, MD

  Abbott Medical Devices

  STUDY DIRECTOR

• Vivian Mao, MD, MPH

  Clinical Science

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 19, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-08

Locations

BE (1)