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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01890135
Eligibility Criteria:
Inclusion Criteria:
* Age \>40 years. Patients less than 40 years of age could well have a form or "thromboangitis obliterans" often called Berger's Disease and the investigators wish to enroll only subjects with atherosclerotic vascular disease.
* Currently taking all standard medications that are part of the "good medical care" for patients with PAD including an anti-platlet agent, an angiotensin-converting enzyme inhibitors or receptor blockers, beta-blockers if indicated for ischemic heart disease, and cholesterol lowering therapy; unless documented contra-indications to these therapies exist. Those patients not on these therapies will be referred back with the suggestion that they be added and they can be re-approached for enrollment at a later date.
* Exercise induced thigh, calf, buttock pain and absence of Rutherford Class IV, V, or VI.3
* A resting ABI of \<0.9 but \>0.4 and the presence of both superficial femoral artery stenosis (70% or greater) disease and below the knee disease with a significant stenosis in at least one of the run-off vessels.
* Absence of critical inflow (iliac or common femoral) disease. The profunda femoral artery is the major source of collateral blood vessels. The investigators initial approach will be to try and enroll as homogenous of a patient population as possible to allow us to focus on the primary endpoint of the study (the change in muscle perfusion to the ischemic limb over time).
* Ability to undergo magnetic resonance imaging and provide informed written consent.
Exclusion Criteria:
* Serious known concomitant disease with life expectancy of less than one year
* Prior amputation or history of critical limb ischemia
* Creatinine clearance (CrCl) \>45 to permit safe administration of the gadolinium contrast agent.
* Recent myocardial infarction, unstable angina, stroke or transient ischemic attack within 3 months.
* American Heart Association Class III or IV congestive heart failure or known left ventricular ejection fraction less than 40%.
* Known history of anemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01890135
Study Brief:
Protocol Section:
NCT01890135