A prospective, single-arm, open-label, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mural SC Semi-Compliant 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
- 89
- 试验地点
- 4
- 主要终点
- 1. Major adverse cardiac events (MACE)
研究概览
简要总结
Mural SC Semi-Compliant Rx PTCA Balloon Dilation Catheter - A Prospective , Single-arm, Multi-center, Post- Market Surveillance Study to Evaluate the Safety and Performance of Mural SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter.
Study Device : Mural SC Semi-Compliant Rx PTCA Balloon Catheter
Indication : The Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mural™ SC Semi-compliant Rx PTCA Balloon Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.
**Objective :**This study aims to evaluate the safety and performance of the Mural™ SC Semi-Compliant Rx PTCA Balloon Dilation Catheter
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 above 18 years, irrespective of gender.
- •Participants must be willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form.
- •The participants should be able to comply with protocol requirements and assessments.
- •Participants with cardiovascular stenosis who are undergoing an endovascular procedure requiring vessel dilatation and treated with Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter.
- •Participants with percutaneous transluminal coronary angioplasty.
- •Participants undergoing treatment for obstructive lesions in a native coronary artery or bypass grafts, or need postdilatation of a coronary stent.
- •Target lesion amenable to treatment with the Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter .
排除标准
- 未提供
结局指标
主要结局
1. Major adverse cardiac events (MACE)
时间窗: 1. Post operative , 7 days , 1 month, 3 months, 6 months, 12 months | 2. Intra Operative
2. Device Success
时间窗: 1. Post operative , 7 days , 1 month, 3 months, 6 months, 12 months | 2. Intra Operative
次要结局
- 1. Procedural Success(2. Target Vessel Revascularization)
研究者
Dr KiranKumar Shetty
Meril Life Sciences Pvt Ltd