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Sound wave device clears calcified leg arteries in new study

NCT ID NCT05007925

Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that uses sound waves to break up calcium buildup in the arteries below the knee in 250 people with peripheral artery disease (PAD). The goal was to safely restore blood flow and avoid serious complications like amputation. Results showed the procedure successfully opened blocked arteries with few major side effects.

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

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

250 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- General Inclusion Criteria 1. Age of subject is ≥ 18. 2. Subject is able and willing to comply with all assessments in the study. 3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. 4. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure. 5. Estimated life expectancy \>1 year. * Angiographic Inclusion Criteria 6. Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs. 7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate. 8. Target lesion with ≥70% stenosis by investigator visual estimate. 9. Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone. 10. Distal reconstitution of at least one pedal vessel (\<50% stenosis) (desert foot excluded). 11. Evidence of at least moderate calcification at the target lesion site by angiography/IVUS OR non-dilatable lesion indicating presence of calcium. Must meet one of the following: 1. Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending \> 50% the length of the lesion. 2. IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm. 3. Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis \> 50% and no serious angiographic complications. Exclusion Criteria: \- General Exclusion Criteria 1. Rutherford Category 0, 1, 2 or 6 (target limb). 2. Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) . 3. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. 4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 5. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 6. Subject has known allergy to urethane, nylon, or silicone. 7. Myocardial infarction within 30 days prior to enrollment. 8. History of stroke within 60 days prior to enrollment. 9. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. 10. Subject is pregnant or nursing. 11. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 12. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. 13. Covid-19 diagnosis within 90 days. 14. The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure. 15. Planned major amputation (of either leg). 16. Acute limb ischemia. 17. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). 18. Subject has an anticipated life span of less than one (1) year. 19. Subject already enrolled into this study. * Angiographic Exclusion Criteria 20. Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g., embolism). 21. Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism ). 22. Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications . 23. Target lesion includes in-stent restenosis. 24. Evidence of aneurysm or thrombus in target vessel. 25. No calcium or mild calcium in the target lesion. 26. Target lesion within native or synthetic vessel grafts. 27. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral artery disease

Contacts and locations

Locations

  • Ascension St Johns Heart & Vascular Center

    Bartlesville, Oklahoma, 74006, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Baylor Scott & White - The Heart Hospital Baylor

    Plano, Texas, 75093, United States

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010, United States

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Charlotte Radiology

    Charlotte, North Carolina, 28202, United States

  • Columbia University Irving Medical Center/NYPH

    New York, New York, 10032, United States

  • Karolinen-Hospital Hüsten

    Arnsberg, 59759, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McLaren Bay Heart and Vascular

    Bay City, Michigan, 48708, United States

  • McLaren Greater Lansing

    Lansing, Michigan, 48910, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Medstar Montgomery Medical Center

    Olney, Maryland, 20832, United States

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803, United States

  • Mt. Sinai Hospital

    New York, New York, 10029, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • North Carolina Heart & Vascular

    Raleigh, North Carolina, 27607, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, Pennsylvania, 17101, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Southcoast Hospitals Group

    New Bedford, Massachusetts, 02740, United States

  • St. Helena Hospital

    St. Helena, California, 94574, United States

  • St. Luke's Hospital

    Kansas City, Missouri, 64111, United States

  • Stanford Hospital

    Palo Alto, California, 94304, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • Texas Health Presbyterian Hospital

    Dallas, Texas, 75231, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • UC Davis Health

    Sacramento, California, 95817, United States

  • UCSF Fresno

    Fresno, California, 93720, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Universitäts-Herzzentrum Freiburg & Bad Krozingen

    Bad Krozingen, 79189, Germany

  • Universitätsklinikum Leipzig AoR

    Leipzig, 04103, Germany

  • Universitätsklinikum der Ruhr-Universitaet Bochum

    Bad Oeynhausen, 32545, Germany

  • VA Puget Sound Health Care Systems - Seattle

    Seattle, Washington, 98108, United States

  • Wellmont Cardiology Services dba CVA Heart Institute

    Kingsport, Tennessee, 37660, United States

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