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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion))
Timeframe: Procedure date through 1-year post-op
Restenosis to ≥ 50% of the target lesion on angiography or follow-up ultrasound
Timeframe: Procedure date through 1-year post-op
Freedom from perioperative death
Timeframe: Procedure date through 30 days post-op
Freedom from major adverse cardiovascular events (MACE (stroke, myocardial infarction (MI), cardiovascular death))
Timeframe: Procedure date through 30 days post-op
Freedom from major adverse events
Timeframe: Procedure date through 6 months post-op