Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Baylor Research Institute
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.
Description
This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwave™ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceShockwave Catheter
Shockwave™ IVL + DCB procedure
- ProcedureCFA Endarterectomy
Standard CFA endarterectomy
Location
- Baylor Scott & White The Heart Hospital - PlanoPlano, Texas