A Prospective, Multi Center, Single Arm, Open Label, Observational, Real World, Post Market Clinical Follow up Study to Evaluate the Safety & Performance of Mural NC Non Compliance Rx PTCA Balloon Dilatation Catheter
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- 1. Procedure Success
研究概览
简要总结
Title : 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.
Study Design : A prospective, multi-center, open-label, single-arm, observational, real-world, post-market clinical follow-up study
**Study 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.
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
- •Participants aged 18 and above, irrespective of gender.
- •Participants with cardiovascular stenosis who are undergoing endovascular procedure requiring vessel dilatation and treated with Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter.
- •Participants with percutaneous transluminal coronary angioplasty.
- •Participants with to treat obstructive lesions of a native coronary artery or aortocoronary bypass, or need post-dilatation of a coronary stent.
- •Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter used in the primary lesion treated during the procedure by the decision physician.
- •Participant who has been provided written informed consent.
排除标准
- •Participants with unprotected left main coronary artery lesions.
- •Participants having coronary artery spasm in the absence of a significant stenosis.
- •Pregnant or lactating women.
- •Participants with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, or materials such as pebax, nylon, stainless steel, polytetrafluoroethylene, sodium hyaluronate, or any contrast media.
- •Participating in another medical device or pharmaceutical clinical trial.
- •The participant who is unwilling or unable to sign the Informed Consent Document.
结局指标
主要结局
1. Procedure Success
时间窗: 1. Intra-operative | 2. Through discharge, 7 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days. | 3.Intraoperative
2. Major Adverse Cardiac events
时间窗: 1. Intra-operative | 2. Through discharge, 7 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days. | 3.Intraoperative
3. Angiographic Success
时间窗: 1. Intra-operative | 2. Through discharge, 7 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days. | 3.Intraoperative
次要结局
- 1. Freedom from Balloon Rupture(2. Freedom from Coronary Perforation)
研究者
Dr KiranKumar Shetty
Meril Life Sciences Pvt. Ltd