Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study
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 medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected 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
- •Turkish citizen,
- •≥18 years of age,
- •Has indication for percutaneous transluminal coronary angioplasty (PTCA),
- •Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent
- •Fluydo NC using in the primary lesion treated during the procedure by the decision physician,
- •Has signed and dated the informed consent.
排除标准
- •Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis.
- •Needs the device use in an unprotected left main coronary artery
- •Device use has not consistent with Instructions for Use.
- •Participating in another medical device or pharmaceutical clinical trial.
结局指标
主要结局
Device success
时间窗: immediately after interventional procedure
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
时间窗: immediately after interventional procedure
Successful inflation, achievement of appropriate diameter, and deflation of the balloon
时间窗: immediately after interventional procedure
Decrease in the percent stenosis after balloon procedure
时间窗: immediately after interventional procedure
No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
时间窗: immediately after interventional procedure
次要结局
- Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.(discharge or 48 hours after index procedure, whichever happens first)
- Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR))(Discharge or 48 hours after index procedure, whichever happens first)