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 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT01507558
Eligibility Criteria:
Inclusion Criteria:
* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)
Exclusion Criteria:
* Patient is simultaneously participating in another investigational drug or device study
* Patient is pregnant or breast-feeding
* Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
* Patient has end-stage renal disease and chronic kidney disease (eGFR\<30)
* Patient has an active infection
* Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
* Patient has a life expectancy of less than one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01507558
Study Brief:
Protocol Section:
NCT01507558