Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age is 18 years old or older
- •Written consent to participate in the study
- •All subjects must be candidates to undergo percutaneous peripheral or coronary diagnostic or interventional procedures where use of a Guide Wire is indicated.
- •Eligible for catheter-based diagnostic or treatment procedure. A representative list of diseases and catheter-based treatments includes:
- •Suspicion of obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing Suspicion of peripheral vascular obstructive disease undergoing elective or urgent diagnostic and/or percutaneous therapeutic procedures.
- •Palpable pulse of the proximal and distal radial artery on one or both arms
- •Subjects must be suitable for a transfemoral vascular access
- •Subjects undergoing elective or urgent percutaneous treatment of symptomatic arterial occlusive disease and intermittent claudication or CLI of the SFA and/or popliteal arteries.
- •Subjects with suspected narrowed or blocked arteries in the heart.
排除标准
- •Inability to provide consent
- •Pregnant or lactating women
- •Subjects actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
- •Subjects with bilateral hand or arm misalignment / paresis that makes a radial access impossible
- •Subject has a known allergy to the Guide Wire materials
- •Subjects with emergent procedures acute ischemia, aneurysmal disease, common femoral or profunda interventions, or hybrid procedures were excluded.
- •Subjects with severe infections
- •Subjects with severe heart failure
- •Subjects with severe physical weakness
结局指标
主要结局
Primary Safety Endpoint
时间窗: up to 15 ± 2 days after the procedure.
Freedom from SADEs during the procedure and up to 15 ± 2 days after the procedure.
Primary Performance Endpoint
时间窗: Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours)
Successful introduction of Guide Wire and deployment of the intended diagnostic or therapeutic catheter according to the IFU, without any device related deficiencies per insertion attempt
次要结局
- Rate of Guide Wire deficiencies;(15 ± 2 days after the procedure)
- Rate of complications:(15 ± 2 days after the procedure)
- Expected number of insertion attempts for a single Guide Wire to reach primary performance endpoint(Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours))
- Expected time to reach the specified position with the Guide Wire(Catheter according to the IFU, insertion attempt to reach deployment(up to< 24 hours))