Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- InnoRa GmbH
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Safety and tolerance
研究概览
简要总结
This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years of age
- •Patients with peripheral arterial occlusive disease and intended for endovascular therapy in the SFA and/or popliteal artery pars I/II
- •Patients suitable for endovascular therapy in the SFA and/or popliteal artery pars I/II with a hyper-compliant balloon without further luminal widening
- •Target vessels with a sufficient "runoff" to the foot with at least one vessel
- •Rutherford classification 1-4 if physical and medicinal therapies have not been successful
排除标准
- •Aneurysms at the site of inflation
- •Application directly in the area of large vessel wall injuries with heavy bleeding
- •Rutherford classification 5 and 6
研究组 & 干预措施
InnoCath AB® Balloon
endovascular treatment of lesions in the superficial femoral artery (SFA) and/or popliteal artery pars I/II without further luminal widening, and/or for short-term interruption of blood flow with the InnoCath AB® hyper-compliant balloon cathe-ters (100 or 200 mm length)
干预措施: InnoCath AB® hyper-compliant balloon catheter (Device)
结局指标
主要结局
Safety and tolerance
时间窗: up to 30 days after intervention
Number of events, which are related to the medical device being tested
次要结局
- Handling of the InnoCath AB® hyper-compliant balloon catheter(throughout the entirety of the procedure)
- Procedural success(till the end of the procedure)
- Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter(throughout the entirety of the procedure)