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依维莫司洗脱生物可吸收血管支架系统治疗心脏移植血管病变:CART(心脏移植修复治疗)前瞻性多中心试点研究。

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

作者信息

Pighi Michele, Tomai Fabrizio, Petrolini Alessandro, de Luca Leonardo, Tarantini Giuseppe, Barioli Alberto, Colombo Paola, Klugmann Silvio, Ferlini Marco, Ormezzano Maurizio Ferrario, Loi Bruno, Calabrò Paolo, Bianchi Renato Maria, Faggian Giuseppe, Forni Alberto, Vassanelli Corrado, Valgimigli Marco, Ribichini Flavio

机构信息

Department of Medicine, University of Verona, Piazzale Aristide Stefani n 1, 37126, Verona, Italy.

Department of Cardiovascular Sciences, European Hospital, Via Portuense, 700, 00149, Rome, Italy.

出版信息

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.

摘要

心脏移植血管病变(CAV)是一种加速性动脉粥样硬化形式,是心脏移植术后晚期发病和死亡的主要原因。最近的生物可吸收血管支架(BVS)技术通过实现短暂支架置入并促进血管愈合,在CAV治疗方面代表了一种潜在的新型治疗工具。符合条件的受试者将使用依维莫司洗脱生物可吸收血管支架(Absorb Everolimus-Eluting BVS,美国加利福尼亚州圣克拉拉市雅培血管公司)进行治疗,并在自首次手术起长达3年的预定时间点进行评估。临床和影像数据将通过专用病例报告表(CRF)收集。所有影像数据将在独立的核心实验室进行分析。本研究的主要目的是评估受CAV影响的心脏移植受者中第二代Absorb BVS在1年时的血管造影表现。

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