Clinical Research Directory

Inclusion Criteria: A patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab): 1. CFA atherosclerotic stenosis 60-100% 2. Moderate to severe calcification reported on imaging 3. Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5 4. Failing conservative therapy 5. Operative candidate for CFE prior to enrollment 6. ≥18 years of age Exclusion Criteria: A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria: 1. History of CFE or bypass in affected limb 2. Thrombosis of affected CFA 3. Aneurysm in the common femoral artery of target limb 4. Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months) 5. Any preceding percutaneous cardiovascular intervention within 2 weeks 6. Inability to tolerate DAPT 7. Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µL 8. Uncontrolled diabetes (HbA1c ≥10.0%) 9. Non-ambulatory 10. Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations 11. MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal)) 12. Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause) 13. Pregnant