Clinical Research Directory

Inclusion Criteria: 1. Age ≥22 2. Diagnosis of infrapopliteal PAD. 3. Rutherford class 3, 4 or 5 as determined by the investigator. 4. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg. Exclusion Criteria: 1. Prior stenting in posterior tibial, anterior tibial or peroneal artery. 2. Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if all other criteria are met). 3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). 4. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease. 5. Acute limb ischemia within 30 days prior to treatment. 6. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 7. Uncontrolled diabetes defined as HbA1c greater than 10%. 8. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data. 9. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study). Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD. For bi-lateral PAD patients only one leg with the more advanced bi-lateral PAD will be treated.