Alvision™ Interventional Cardiology Diagnostic Catheter Use for Routine Diagnostic Procedures in Angiographic Applications: Evaluation of Safety and Performance in Everyday Clinical Practice. The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) 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
- Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:
研究概览
简要总结
The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice
详细描述
Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.
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 a diagnostic coronarography according to Alvision™ Instruction for use,
- •Has signed and dated the informed consent.
排除标准
- •Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
- •Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
- •Participating in another medical device or pharmaceutical clinical trial
结局指标
主要结局
Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:
时间窗: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
* Thrombus formation/emboli * Arterial wall damage * Myocardial infarction * Plaque dislodgement * Cardiac arrhythmia * Death * Stroke
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.
时间窗: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
次要结局
- Ratio of the successfully insertion catheter(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)
- Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)
- Capacity of providing the doctor with a safe and effective tool to perform angiographies(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)
- Determination of the relation between catheter size, and patients' height.(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)
- Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)