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.

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

PIGHI, Michele;FAGGIAN, Giuseppe;FORNI, ALBERTO;VASSANELLI, Corrado;RIBICHINI, Flavio Luciano
2016-01-01

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.
2016
Cardiac allograft vasculopathy; Everolimus-eluting bioresorbable vascular scaffold; Heart transplant; Allografts; Cardiac Catheterization; Cardiovascular Agents; Clinical Protocols; Coronary Artery Disease; Everolimus; Heart Transplantation; Humans; Italy; Pilot Projects; Prospective Studies; Prosthesis Design; Research Design; Time Factors; Treatment Outcome; Absorbable Implants; Coated Materials, Biocompatible
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/958167
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