NCT05445258终止不适用
Evaluation of the Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon Catheters in Peripheral Arteries
适应症
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
- 4
- 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
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)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast CancerSolid Tumors and LymphomasNCT02392611Gilead Sciences33
已完成
1 期
Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric CancerGastric CancerEsophageal CancerNCT00113581Merck KGaA, Darmstadt, Germany26
Unknown
不适用
Robotic-assisted Percutaneous Transhepatic PunctureLiver DiseasesNCT06195917Zhongda Hospital20
已完成
1 期
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453HealthyNCT02052687Novartis Pharmaceuticals41
已完成
1 期
Testing safety of a live bacterial therapy for the treatment of Chronic ConstipatioFunctional Constipation (FC)Irritable Bowel Syndrome - Constipation (IBS-C)Idiopathic Constipation (IC)Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12620001077954Servatus Ltd38