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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT03490968
Eligibility Criteria:
Inclusion/exclusion criteria for Healthy Subjects
Inclusion criteria
* Male or female, age ≥ 50 years old
* Non-smoker
Exclusion criteria
* Presence of peripheral artery disease
* History of a heart attack or stroke
* Diabetes
* Active cancer
* Severe renal disease (CrCl \< 60)
* Severe liver disease
* Active rheumatological diseases
Inclusion/exclusion criteria for PAD Subjects
Inclusion criteria
* Male or female, age 50 years or older
* Atherosclerotic PAD, ABI ≤0.85
* Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
* For Aim 3, subjects will have Rutherford stage 4 or 5 disease
* For Aim 3, subjects will be undergoing revascularization as standard of care
Exclusion criteria
* Presence of a femoral, popliteal or tibial aneurysm of the index limb
* Life expectancy less than 2 years
* A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
* Renal dysfunction defined as MDRD eGFR ≤ 20ml/min/173 m2 at the time of screening
* Currently on dialysis or history of a renal transplant
* Cirrhosis or active hepatitis
* A documented hypercoagulable state
* Myocardial infarction within 6 months
* Stroke within 6 months
* Nonatherosclerotic occlusive disease of the lower extremity
* Any prior infrainguinal revascularization on index limb
* Current immunosuppressive medication, chemotherapy or radiation therapy
* Inability to have an MRI
* Exercise limitation aside from that due to PAD (i.e. COPD, degenerative joint disease, etc.)
* Women who are pregnant
* Women who are nursing
* Primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03490968
Study Brief:
Protocol Section:
NCT03490968