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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00274157
Eligibility Criteria:
Inclusion Criteria:• Males and female between 40 and 85 years of age
* subjects referred to The Cleveland Clinic Foundation for a catheter-based revascularization procedure as treatment of intermittent claudication
* Leg symptoms consistent with intermittent claudication for a period of at least 3 months
* Ankle-brachial index (ABI) in the leg to be revascularized must be \< 0.90 or demonstration of post exercise fall in ABI to \< 0.9 for subjects with aortoiliac disease
* Subjects scheduled for both aortoiliac and/or femoropopliteal revascularization procedures will be eligible
* Subjects with bilateral leg symptoms may be enrolled, as long as bilateral revascularization procedures are planned
Exclusion Criteria:
* • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies
* Critical limb ischemia (rest pain, non-healing ulcer, gangrene)
* Contraindication to contrast arteriography
* Vascular surgery or prior catheter-based vascular intervention within the preceding 6 months
* Patients with suspected or confirmed graft stenoses or occlusions
* Myocardial infarction or hospitalization for unstable angina, coronary artery bypass grafting or percutaneous coronary intervention, within the preceding one month
* Stroke or transient ischemic attack within the preceding one month
* Pregnancy or planned pregnancy during the one year of participation in the trial.
* Any active chronic inflammatory condition,including autoimmune disorder or active malignancy.Subjects unable to walk, amputees, and subjects with a contraindication to treadmill exercise.
* Patients with dementia or other significant cognitive impairment
* Patients who are non-English speaking, (due to the need for subjects to complete standardized questionnaires)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT00274157
Study Brief:
Protocol Section:
NCT00274157