Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Compar… (NCT06829914) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
United States60 participantsStarted 2024-03-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. CFA atherosclerotic stenosis 60-100%
. Moderate to severe calcification reported on imaging
. Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5
. Failing conservative therapy
. Operative candidate for CFE prior to enrollment
. ≥18 years of age
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion))
Timeframe: Procedure date through 1-year post-op
2
Restenosis to ≥ 50% of the target lesion on angiography or follow-up ultrasound
Timeframe: Procedure date through 1-year post-op
3
Freedom from perioperative death
Timeframe: Procedure date through 30 days post-op
4
Freedom from major adverse cardiovascular events (MACE (stroke, myocardial infarction (MI), cardiovascular death))
Timeframe: Procedure date through 30 days post-op
5
Freedom from major adverse events
Timeframe: Procedure date through 6 months post-op