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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.

NCT01759290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2016-10-19

Study results available
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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

Interventions

DEVICE

Absorb Bioresorbable Vascular Scaffold

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ashok Seth, MD · Fortis Escorts Heart Institute, New Delhi

  • Eric Eeckhout, MD, PhD · Centre Hospitalier Universitaire Vaudois

  • Peter Staehr, MD · Abbott Medical Devices

  • Vivian Mao, MD, MPH · Clinical Science

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01759290 on ClinicalTrials.gov