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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT00424450
Eligibility Criteria:
Inclusion Criteria:
* male or females \> 18 years old
* PAD Fontaine stages IIb, III or IV
* conventional angiography or magnetic resonance angiography
* a severe lesion (≥80% stenosis with a peak velocity ratio intrastenotic / prestenotic ≥4.0 in Duplex ultrasound or occlusion) has to be present in the common or external iliac, common or superficial femoral, popliteal or one or more infrapopliteal arteries, which is accessible to revascularization
* indication for revascularization, i.e. lower limb artery bypass surgery or PTA (based on the treating physician's decision)
* revascularization appointed within the next 6 weeks of study inclusion
* patients, who have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for the required follow-up
Exclusion Criteria:
* failed or incomplete revascularization
* patients with chronic heart failure NYHA IV
* patients with acute coronary syndrome
* patients with severe pulmonary hypertension
* patients who are assigned to conservative PAD treatment (according to the treating physician's decision)
* refusal or inability to give informed consent
* patients who are enrolled into another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00424450
Study Brief:
Protocol Section:
NCT00424450