Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study

J Cardiovasc Transl Res. 2016 Feb;9(1):40-8. doi: 10.1007/s12265-015-9665-x. Epub 2015 Dec 18.

Abstract

Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents the leading cause of late morbidity and mortality after heart transplantation. The recent bioresorbable vascular scaffold (BVS) technology represents a potential novel therapeutic tool, in the context of CAV, by allowing transient scaffolding and concomitant vessel healing. Eligible subjects will be treated by using the Absorb Everolimus-Eluting BVS (Abbott Vascular, Santa Clara, CA, USA), and evaluated at pre-determined time points, up to 3 years since the index procedure. Both clinical and imaging data will be collected in dedicated case report forms (CRF). All imaging data will be analyzed in an independent core laboratory. The primary aim of the study is to evaluate the angiographic performance at 1 year of second-generation Absorb BVS, in heart transplant recipients affected by CAV.

Trial registration: ClinicalTrials.gov NCT02377648.

Keywords: Cardiac allograft vasculopathy; Everolimus-eluting bioresorbable vascular scaffold; Heart transplant.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Allografts
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiovascular Agents / adverse effects
  • Clinical Protocols
  • Coated Materials, Biocompatible*
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / etiology
  • Coronary Artery Disease / therapy*
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Heart Transplantation / adverse effects*
  • Humans
  • Italy
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Design
  • Research Design
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Everolimus

Associated data

  • ClinicalTrials.gov/NCT02377648