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.
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
Dr Mahesh Nalin Kumar
St Gregorios Medical Mission Multi-Specialty Hospital
