A Prospective , Single arm , Multi center, Observational study to Evaluate the Safety and Performance of Mural DES Sirolimus Eluting Coronary Stent System in a real world setting
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 6
- 主要终点
- 1. Target Lesion Failure
研究概览
简要总结
Study Name : A prospective, multi-center, open-label, single-arm, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mural NC Non-compliant Rx PTCA Balloon Dilatation Catheter
S**tudy Objective :**This study aims to evaluate the safety and performance of Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter in Participants with cardiovascular stenosis who will undergo an endovascular procedure requiring vessel dilatation
**Study Design :**A prospective, multi-center, single-arm, open-label, observational, real-world, post-market clinical follow-up study.
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
- •1.The participant must be aged 18 years or older, irrespective of gender.
- •Participant diagnosed with coronary artery disease (CAD)requiring revascularization, such as stable angina, unstable angina, acute myocardial infarction (STEMI or NSTEMI),silent ischemia with evidence of significant coronary artery disease.
- •Participants with single or multiple coronary artery lesions are eligible for stenting.
- •Participant with De novo coronary artery lesions.
- •The participant must be willing and able to provide written Informed Consentby signing and dating the IRB or ECapproved Informed Consent form.
- •The participant is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •1.Participants have any known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media.
- •2.Life expectancy of less then 1 year will be excluded.
- •Pregnant women will be excluded.
- •4.Participants known to have a lesion that prevents complete inflation of an angioplasty balloon.
- •5.Transplant participants.
- •Participant with active gastrointestinal bleeding or history of gastrointestinal bleeding within the past 6 months.
- •The participant is not willing and able to comply with postoperative scheduled clinical evaluations.
结局指标
主要结局
1. Target Lesion Failure
时间窗: 1. 1 week , 1 month, 3 months, 6 months , 1 year | 2. Through Discharge, 7 days , 30 days , 3 months , 6 months , 1 Year | 3. Intra operative | 3. Device Success
2. Major Adverse Cardiac Events
时间窗: 1. 1 week , 1 month, 3 months, 6 months , 1 year | 2. Through Discharge, 7 days , 30 days , 3 months , 6 months , 1 Year | 3. Intra operative | 3. Device Success
3. Device Success
时间窗: 1. 1 week , 1 month, 3 months, 6 months , 1 year | 2. Through Discharge, 7 days , 30 days , 3 months , 6 months , 1 Year | 3. Intra operative | 3. Device Success
次要结局
- 1. Target Vessel Revascularization(2. Stent Thrombosis)
研究者
Dr KiranKumar Shetty
Meril Life Sciences Pvt. Ltd