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:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT02307292
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Single target de novo superficial femoral artery lesion (angiographic evidence of \>50% Stenosis or occlusion) by visual estimate
* Rutherford category II-IV
* At least one patent outflow artery to the ankle.
* Patient signed the informed consent
Exclusion Criteria:
* Patient with acute or subacute Thrombus
* Patients with hyperkoagulopathy
* Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible
* Pregnancy or positive pregnancy test
* Previous enrolment in this Trial or other industrial Trials
* Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02307292
Study Brief:
Protocol Section:
NCT02307292