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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT02387658
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* At least 18 years old
* Unilateral lower limb claudication Rutherford class 2-4
* Subjects must be able to complete screening six minute walk, walking impairment questionnaire, and baseline ankle brachial index
* Estimated survival ≥1 year in the judgment of the primary operator
* Documented symptomatic femoropopliteal (FP) atherosclerotic disease with at least moderate angiographic stenosis in the symptomatic lower extremity
* Subjects with multilevel disease can be screened and enrolled after treatment of other non FP PAD
Exclusion Criteria:
* Life expectancy less than 12 months or other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
* Severe Bilateral claudication
* Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
* Known hypersensitivity to adenosine or moderate to severe asthma
* Pregnancy
* Serum Creatinine \>2.5
* Vascular graft, aneurysm or postsurgical stenosis of the target vessel
* Documented untreated severe iliac or below-the knee stenosis with \< 2 vessel run-off in leg with femoropopliteal stenosis or untreated bilateral symptomatic peripheral arterial disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02387658
Study Brief:
Protocol Section:
NCT02387658