跳至主要内容
临床试验/CTRI/2025/04/085082
CTRI/2025/04/085082尚未招募不适用

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

Meril Life Sciences Indian Private Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Target Lesion Failure (TLF)

研究概览

简要总结

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 BioMime™ 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 BioMime™ 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 coronary heart disease who were implanted with 60 mm of BioMime™ Morph SES System.

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)

时间窗: Through 1 Year

- Defined as the composite of cardiovascular death, target vessel

时间窗: Through 1 Year

myocardial infarction (TV-MI) and target lesion revascularization (TLR)

时间窗: Through 1 Year

次要结局

  • Device success(During Procedure)
  • Cardiovascular death(Through 1 Year)
  • Target Vessel Myocardial Infarction (TV-MI)(Through 1 Year)
  • Target Lesion Revascularization (TLR)(Through 1 Year)
  • Target Vessel Failure (TVF)(Through 1 Year)
  • Target Vessel Revascularization (TVR)(Through 1 Year)
  • Stent thrombosis(Through 1 Year)
  • Stroke(Through 1 Year)
  • Procedure success(At Discharge)

研究者

发起方
Meril Life Sciences Indian Private Limited
申办方类型
Other [Medical Device Company]
责任方
Principal Investigator
主要研究者

Dr Pushpraj Patel

Golden Heart Hospital

研究点 (1)

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