Shockwave Versus Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Design and Rationale of the SHOCKIFY Trial

Abstract

Background

Calcified atherosclerotic disease in the lower extremities can lead to severe symptoms, including lifestyle-limiting claudication and chronic limb-threatening ischemia. Although surgical endarterectomy remains the gold standard treatment for symptomatic common femoral artery (CFA) stenosis, intravascular lithotripsy (IVL) combined with a drug-coated balloon (DCB) has shown potential as a safe and effective alternative. However, the long-term efficacy of this approach is not well-established.

Methods

The SHOCKwave angioplasty versus surgical endarterectomy for severe calcified common femoral artery stenosis: effIcacy/saFetY (SHOCKIFY) trial is a single-site, prospective, randomized clinical trial comparing IVL with DCB to surgical endarterectomy in the management of CFA stenosis. Eligible subjects will be randomized in a 1:1 manner to receive either IVL with DCB treatment or endarterectomy. The primary end points include 6-month safety, defined as freedom from perioperative death, major adverse cardiovascular events, and major adverse limb events, along with 1-year efficacy, measured by primary patency. Secondary end points include follow-up assessments at 30 days, 6 months, and 1 year for ankle-brachial index, Rutherford chronic limb-threatening ischemia classification, patient satisfaction, and quality of life metrics. Specifically, patency will be evaluated at 30 days and 6 months as part of the secondary end points. These metrics will be assessed through the Short Form-36 quality of life survey, the peripheral artery questionnaire, and the walking impairment questionnaire. Patient-reported outcomes will be analyzed at these follow-up intervals.

Conclusions

This trial aimed to assess whether IVL with DCB is a viable, noninferior alternative to the traditional surgical endarterectomy, potentially offering a safer, minimally invasive option for CFA stenosis. The results may reform the future of CFA treatment guidelines by providing robust, randomized data on the clinical utility of IVL in managing complex vascular calcification.