Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold The FANTOM II Study
Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold The FANTOM II Study
复制标题
DOI：
10.1161/circinterventions.118.007283
复制
发表时间：
2019-06-01
影响因子：
5.6
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
--
作者：
Chevalier, Bernard;Abizaid, Alexandre;Stone, Gregg W.
背景：一种新型生物可吸收支架，西罗莫司洗脱 Fantom，包含不透射线聚合物、厚度为 125 μm 的支柱和 1.35 mm 的横截面。本研究的目的是评估 FANTOM 支架在较大患者群体中的 9 个月血管造影和 12 个月临床结果。 方法和结果：FANTOM II 研究（Fantom 西罗莫司洗脱生物可吸收冠状动脉支架的安全性和性能研究 - 初始 24 个月结果的第一份报告）是一项前瞻性、多中心试验，入组了 240 名单发冠状动脉狭窄患者，并有参考价值。血管直径 2.5 至 3.5 毫米 直径和病变长度
BACKGROUND: A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 mu m, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population.METHODS AND RESULTS: The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length