Sound waves vs. scalpel: new study tests shockwave therapy for blocked leg arteries
NCT ID NCT06829914
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a new, less invasive shockwave device to standard surgery for treating severe calcium buildup in the main leg artery. The shockwave uses sound waves to break up the calcium, while surgery involves physically removing the blockage. Researchers want to see if the shockwave is as safe and effective as surgery for improving blood flow and preventing future problems. The trial involves 60 people with severe leg pain or tissue damage due to blocked arteries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shockwave catheter (a device that uses sound waves to break up calcium in arteries)
- What this could lead to
- If successful, this could offer a less invasive alternative to surgery for people with severely blocked leg arteries, potentially reducing recovery time and complications.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The shockwave procedure may not be as durable as surgery, and there is a risk of artery damage or blockage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 or she meets any of the following criteria: 1. History of CFE or bypass in affected limb 2. Thrombosis of affected CFA 3. Aneurysm in the common femoral artery of target limb 4. Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months) 5. Any preceding percutaneous cardiovascular intervention within 2 weeks 6. Inability to tolerate DAPT 7. Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µL 8. Uncontrolled diabetes (HbA1c ≥10.0%) 9. Non-ambulatory 10. Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations 11. MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal)) 12. Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause) 13. Pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
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