ABSORB II randomized controlled trial. A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: Rationale and study design
ABSORB II randomized controlled trial. A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: Rationale and study design
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DOI：
10.1016/j.ahj.2012.08.010
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发表时间：
2012-11-01
影响因子：
4.8
通讯作者：
Chevalier, Bernard
中科院分区：
文献类型：
--
作者：
Diletti, Roberto;Serruys, Patrick W.;Chevalier, Bernard
背景：目前尚无吸收维罗莫司洗脱生物可吸收支架与传统金属药物洗脱支架的直接比较资料。方法吸收II研究是一项随机、主动对照、单盲、多中心临床试验，旨在比较第二代吸收维罗莫司洗脱金属支架和XIENCE维罗莫司洗脱金属支架。大约501名受试者将在欧洲和新西兰的大约40个研究地点以2：1的随机基础进行登记(吸收BVS/XIENCE支架)。治疗的病变将多达2个新的天然冠状动脉病变，每个病变位于不同的主要心外膜血管，所有的血管造影最大管腔直径(QCA)估计在2.25到3.8毫米之间，病变长度为
Background Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents.Methods The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of