Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon
- Conditions
- Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II
- Interventions
- Device: InnoCath AB® hyper-compliant balloon catheter
- Registration Number
- NCT05445258
- Lead Sponsor
- InnoRa GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- Aneurysms at the site of inflation
- Application directly in the area of large vessel wall injuries with heavy bleeding
- Rutherford classification 5 and 6
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description InnoCath AB® Balloon InnoCath AB® hyper-compliant balloon catheter 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)
- Primary Outcome Measures
Name Time Method Safety and tolerance up to 30 days after intervention Number of events, which are related to the medical device being tested
- Secondary Outcome Measures
Name Time Method Handling of the InnoCath AB® hyper-compliant balloon catheter throughout the entirety of the procedure The handling of the InnoCath AB® hyper-compliant balloon catheter will be evaluated by the investigator, who assesses various parameters using a scale from 0-2, where 0 describes the better outcome; e.g. balloon deflation and withdrawal of balloon catheter: 0=easy, without any problems, 1=difficult, abnormal, 2=not possible.
Procedural success till the end of the procedure defined as technical success (ability of the InnoCath AB® hyper-compliant bal-loon catheter to perform as intended, inflation of the device at the lesion site and retraction of the balloon catheter through the introductory sheath) in the ab-sence of vessel rupture, distal embolization, thrombosis, access complications, and major adverse cardiovascular events (cardiac death, myocardial infarction, stroke) as a consequence of the procedure and related to the study device till the end of the procedure
Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter throughout the entirety of the procedure The device deficiencies of the InnoCath AB® hyper-compliant balloon catheter will be assessed by the investigator as free-text. Device deficiencies means any inadequacy in the identity, quali-ty, durability, reliability, safety or performance of an investigational device, including malfunc-tion, use errors or inadequacy in information supplied by the manufacturer
Trial Locations
- Locations (2)
Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus
🇩🇪Berlin, Germany
Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus
🇩🇪Berlin, Germany