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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01177033
Eligibility Criteria:
Inclusion Criteria:
* Patient is able to verbally acknowledge and understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol.
* Age ≥ 50 and ≤ 85 years old.
* Intermittent claudication (IC) class 2 or 3 (Rutherford) assessed by treadmill testing or 6-Minute Walk Test.
* Lasting \>3 months.
* Failed conservative therapy and the patient's desire for further treatment.
* Atherosclerotic single or multiple stenoses (\>50%) or an occlusion of the Superficial Femoral Artery (SFA) with a target lesion length of 10-20 cm without involvement of the common/deep femoral artery and/or the popliteal artery confirmed by duplex ultrasound and angiography.
* At least one patent tibioperoneal artery with no stenosis \>50% in diameter. Technical and morphological accessibility for both catheter intervention and bypass surgery.
* Absence of other disease that would limit exercise (e.g. angina or chronic respiratory disease).
Exclusion Criteria:
* \>50% stenosis or occlusion of the iliac, the common, the deep femoral or the popliteal artery.
* Surgical reconstruction or catheter intervention on the index leg within the last six months.
* Unsuitability of treadmill testing / Six-Minute Walk Test. Chronic limb ischemia (intermittent claudication class 2 to 6) on the contralateral leg.
* Known allergy to contrast agents containing iodine.
* Contraindication for antiplatelet agents or anticoagulants.
* Clinically manifested heart insufficiency (NYHA III, IV) and/or uncorrected hyperthyreosis.
* Serious general disease state with an estimated life expectancy \< 2 years (ASA IV, V).
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01177033
Study Brief:
Protocol Section:
NCT01177033