Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT05445258
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05445258
Study Brief:
Protocol Section:
NCT05445258