Shockwave™ Vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes

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-threateningischemia (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 thealleviation 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 footreconstruction or non-traditional transmetatarsal amputations

11. MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segmentdeviation and troponin higher than 2 times the upper limit of normal))

12. Stroke within 3 months (defined as sudden transient or irreversible focalneurological deficit resulting from a cerebrovascular cause)

13. Pregnant