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.
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
Dr Satish Suryavanshi
SMC Heart Institute and IVF Research Centre
