NCT05904951已完成不适用
Balloon Dilatation Catheter for the Dilation of Stenotic Atherosclerotic Lesions in Coronary Artery or Bypass Grafts: Evaluation of Safety and Performance in Everyday Clinical Practice. The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
Alvimedica1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Device success
研究概览
简要总结
The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be a Turkish citizen,
- •To be >18 years of age,
- •Lesion must be successfully crossed with a guidewire without complication,
- •INVADER™ PTCA is used in the primary lesion treated during the procedure,
- •Patient has signed and dated the informed consent.
排除标准
- •Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.
- •Device use not consistent with Instructions for Use (IFU).
- •Patients concurrently participating in another medical device or pharmaceutical clinical trial.
结局指标
主要结局
Device success
时间窗: 48 hours after index procedure
Measurement: Percentage of lesions among all attempted lesions with: * Successful device delivery, and * Successful inflation, achievement of appropriate diameter, and deflation of the balloon, and * Decrease in the percent stenosis after balloon procedure, and * No perforation, flow-limiting dissection or reduction in TIMI flow grade, and * No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
次要结局
- Procedural success:(48 hours after index procedure)
- Rate of Target Lesion Failure (TLF)(48 hours after index procedure)
- Rate of individual components of device success(48 hours after index procedure)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) ProcedurePeripheral Arterial DiseaseNCT01849601Acotec Scientific Co., Ltd167
招募中
不适用
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower ExtremityIschemiaAtherosclerosisNCT05158257Xuanwu Hospital, Beijing144
Unknown
不适用
A Study of Balloon Dilatation for the Treatment of Benign Ureteral StrictureStricture UreterNCT04021901Changhai Hospital420
已完成
不适用
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES ImplantationCoronary Artery DiseaseNCT05368129Nanjing First Hospital, Nanjing Medical University48
Unknown
不适用
Endotracheal Dilator to Improve OxygenationTracheal StenosisAirway DiseasePediatric Respiratory DiseasesNCT03411928University of Cape Town12