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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT04252950
Eligibility Criteria:
Inclusion Criteria:
* Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
* Patients with focal and/or diffuse peripheral artery disease
* Bilateral Revascularization patients will also be included
* Ability to participate in an exercise program
Exclusion Criteria:
* Lower extremity amputation(s) which interfere(s) with walking on the treadmill
* Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
* PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis).
* Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
* Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
* Individuals who have had a myocardial infarction within 3 months prior to screening
* Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
* Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
* Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening. Patients can be reconsidered for study inclusion following a 1-month washout period
* Poorly controlled diabetes defined as glycated hemoglobin \>12%
* Abnormal results of blood work not conducive to safely participate in an exercise trial (e.g., anemic, electrolyte abnormalities)
* Inability to speak English
* Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT04252950
Study Brief:
Protocol Section:
NCT04252950