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

NCT ID: NCT01759290

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Absorb Bioresorbable Vascular Scaffold

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Absorb Bioresorbable Vascular Scaffold

Intervention Type: DEVICE

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Interventions

Absorb Bioresorbable Vascular Scaffold

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashok Seth, MD

Role: PRINCIPAL_INVESTIGATOR

Fortis Escorts Heart Institute, New Delhi

Eric Eeckhout, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Peter Staehr, MD

Role: STUDY_DIRECTOR

Abbott Medical Devices

Vivian Mao, MD, MPH

Role: STUDY_DIRECTOR

Clinical Science

Locations

Abbott Vascular International BVBA

Brussels, , Belgium

Countries

Belgium

Other Identifiers

12-302

Identifier Type: -

Identifier Source: org_study_id