Actively Recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Led by Baylor Research Institute · Updated on 2025-10-08
60
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Common femoral artery (CFA) atherosclerotic stenosis between 60% and 100% confirmed by core lab
- Moderate to severe calcification seen on imaging
- Lifestyle-limiting intermittent claudication or chronic limb-threatening ischemia classified as Rutherford category 2 to 5
- Failure of conservative therapy
- Candidate for surgical common femoral endarterectomy before enrollment
- At least 18 years of age
You will not qualify if you...
- History of common femoral endarterectomy or bypass surgery on affected limb
- Thrombosis of the affected common femoral artery
- Aneurysm in the common femoral artery of target limb
- Known restenosis of target lesion within 3 months with narrowing of 50% or more
- Percutaneous cardiovascular intervention within 2 weeks prior
- Inability to tolerate dual antiplatelet therapy (DAPT)
- Known bleeding disorders or thrombocytopenia with platelet count below 100,000/µL
- Uncontrolled diabetes with HbA1c 10.0% or higher
- Non-ambulatory status
- Extensive tissue loss requiring amputation or complex foot reconstruction
- Myocardial infarction within 6 weeks
- Stroke within 3 months
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
Research Team
B
Bonnie Ostergren
CONTACT
S
Sarah Hale
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here