Post-market evaluation of safety & performance of Pipit-NC PTCA Balloon Dilatation Catheter in patients with stenotic coronary arteries during percutaneous coronary intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- 1. Device Success
研究概览
简要总结
This is a prospective, observational, multi-center, single-arm, investigator-initiated study. A total of 87 consecutive patients who will be treated with at least one Pipit-NC PTCA balloon dilatation catheter during their index procedure (pre-dilation and/or post-dilation after stent deployment) will be enrolled according to routine clinical practice. A separate Pipit-NC PTCA balloon dilatation catheter will be used for pre-dilation, and post-dilation after stent deployment. The Pipit-NC PTCA balloon dilatation catheter will be used in multiple lesions, but data from the first treated lesion will be used for the analysis of primary and secondary outcomes.
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 must be at least 18 years of age
- •Patient or a legally authorized representative must provide written informed consent prior to any study related procedure
- •Patient must agree not to participate in any other clinical study during hospitalisation for the index procedure
- •Target lesion(s) can be treated with Pipit-NC PTCA Balloon Dilatation Catheter as per the current IFU.
排除标准
- •Patient not meeting any of the above inclusion criteria.
结局指标
主要结局
1. Device Success
时间窗: Baseline | (From the start to end of the interventional procedure)
2. Procedural success
时间窗: Baseline | (From the start to end of the interventional procedure)
次要结局
- Individual procedural parameters(- Coronary perforation)
- Safety endpoints(- All-cause mortality)