跳至主要内容
临床试验/CTRI/2024/06/069583
CTRI/2024/06/069583已完成不适用

A retrospective, single-center, observational study to assess the safety and performance of BioMime Morph Sirolimus Eluting Coronary Stent System in patients with symptomatic ischemic heart disease.

SMC Heart Institute and IVF Research Centre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Target Lesion Failure (TLF): Defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)

研究概览

简要总结

Data to be collected between 1st January 2021 and 31st December 2022.

Cardiovascular disease is a leading cause of global mortality, with coronary heart disease posing a significant burden. While DES has revolutionized interventional cardiology, concerns like late stent thrombosis have driven ongoing DES advancements. A single long-tapered BioMime Morph SES system is often enough for treating long diffused lesion in tapered arteries, and therefore, the local arterial walls can be saved from over-exposure to drug/metal and its related adverse events such as delayed healing, peri-procedural MI, risk of target lesion revascularization and very late ST, which are caused due to use of multiple stents. The BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System represents a new generation of DES, featuring a unique stent morphology, advanced sirolimus-eluting technology, and biocompatible polymer coatings. Therefore, this study aims to assess the clinical safety and performance of the BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with symptomatic ischemic heart disease who were implanted with BioMimeâ„¢ Morph SES System between 1st January 2021 and 31st December 2022.

排除标准

  • As this is a retrospective study, there are no formal exclusion criteria for the study.

结局指标

主要结局

Target Lesion Failure (TLF): Defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)

时间窗: 1 Year

次要结局

  • 1. Cardiovascular death [Time Frame: Through 1 year](2. Target Vessel Myocardial Infarction (TV-MI) [Time Frame: Through 1 year])

研究者

发起方
SMC Heart Institute and IVF Research Centre
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Satish Suryavanshi

SMC Heart Institute and IVF Research Centre

研究点 (1)

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