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

Summary

The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.

Eligibility

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

Conditions3

Locations1 site

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