Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II
Conditions
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.
Interventions
DEVICEInnoCath 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)
Sponsors
InnoRa GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Aneurysms at the site of inflation * Application directly in the area of large vessel wall injuries with heavy bleeding * Rutherford classification 5 and 6
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerance | up to 30 days after intervention | Number of events, which are related to the medical device being tested |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Countries
Germany
Outcome results
None listed