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A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Trial Profile

A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Oct 2019

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At a glance

  • Drugs Everolimus (Primary)
  • Indications Coronary artery restenosis
  • Focus Therapeutic Use
  • Acronyms ABSORB IV
  • Sponsors Abbott Vascular
  • Most Recent Events

    • 24 Sep 2019 Planned primary completion date changed from 1 Sep 2017 to 1 Apr 2022.
    • 03 Oct 2018 Planned End Date changed from 1 Apr 2024 to 1 Apr 2022.
    • 25 Sep 2018 According to results published in the Lancet Journal, during enrolment for this study, it became evident from earlier studies, that BVS was associated with an excessive rate of device thrombosis compared with metallic DES and this risk typically emerged within 30 days and the study protocol was revised with change in primary endpoint (target lesion failure) time frame from 1 year to 30 days to afford earlier public disclosure of the results.
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