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Design of the study device will be modified
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InnoCath AB® Balloon | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InnoCath AB® hyper-compliant balloon catheter | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerance | Number of events, which are related to the medical device being tested | up to 30 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Werk, Dr | Martin-Luther-Krankenhaus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Diagnostische und Interventionelle Radiologie Evangelisches Krankenhaus Hubertus | Berlin | 14129 | Germany | |||
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| till the end of the procedure |
| Handling of the InnoCath AB® hyper-compliant balloon catheter | 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. | throughout the entirety of the procedure |
| Device deficiencies of the InnoCath AB® hyper-compliant balloon catheter | 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 | throughout the entirety of the procedure |
| Klinik für Radiologie und Nuklearmedizin Martin-Luther-Krankenhaus |
| Berlin |
| 14193 |
| Germany |