跳至主要内容
临床试验/CTRI/2025/12/098464
CTRI/2025/12/098464尚未招募不适用

A Prospective, Single Centre, Observational, 12-months follow-up, clinical evaluation study to investigate the safety and performance of the M’Sure-S, Sirolimus Eluting Coronary Stent System in coronary artery lesion.

Multimedics LLP1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月1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
200
试验地点
1
主要终点
To prospectively analyze the safety profile of the M’Sure-S, Sirolimus Eluting Coronary Stent in patients who underwent percutaneous coronary intervention (PCI) for coronary artery lesions.

研究概览

简要总结

**Study Objectives-**1.      To prospectively analyse the safety profile of the M’SURE-S, Sirolimus Eluting Coronary Stent in patients who underwent percutaneous coronary intervention (PCI) for coronary artery lesions. To prospectively evaluate the performance of the M’SURE-S, Sirolimus Eluting Coronary Stent in terms of major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), and clinical outcomes at 12-month follow-up.

Primary endpoint- Major Adverse Cardiac Events (MACE), defined as composite endpoint of cardiac death, Myocardial infarction (MI) and Target Lesion Revascularization (TLR) at 12 months.

Secondary endpoints- 1.      Clinical device and procedural success.

·         Device Success is defined as the achievement of a final residual in-stent diameter stenosis of < 30% (visual estimate).

·         Procedure success is defined as the achievement of a final in-stent diameter stenosis of < 30% (by visual estimate) without the occurrence of MACE during the hospital stay (up to 7 days if the subject still in the hospital).

2.      Telephonic follow up for all study patients at 12-months post-procedure.

3.      Composite rate of any death (cardiac death, vascular death, or non-cardiac death) at 12-months post-procedure.

4.      Composite rate of cardiac death, any target vessel MI (QMI or NQMI),

and TLR (PCI or CABG, CI vs. non-CI) at 12-months post-procedure.

5.      Device malfunctions at 12-months post-procedure.

6. Serious adverse events at 12-months post-procedure.

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

  • Patient with an age greater than 18 years.

排除标准

  • The subject is participating in another device or drug study.
  • Female patients with a known pregnancy or who are lactating.
  • Current medical condition with a life expectancy of less than 12months.

结局指标

主要结局

To prospectively analyze the safety profile of the M’Sure-S, Sirolimus Eluting Coronary Stent in patients who underwent percutaneous coronary intervention (PCI) for coronary artery lesions.

时间窗: 6 month, 9 month and 12 month

次要结局

  • To prospectively evaluate the performance of the M’Sure-S, Sirolimus Eluting Coronary Stent in terms of major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), and clinical outcomes at 12-months follow-up.(6 month, 9 month and 12 month)

研究者

发起方
Multimedics LLP
申办方类型
Other [Medical Device Manufacturer]
责任方
Principal Investigator
主要研究者

Dr Mahesh Nalin Kumar

St Gregorios Medical Mission Multi-Specialty Hospital

研究点 (1)

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