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Sound waves could blast away artery blockages without surgery

NCT ID NCT05858905

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests a new device that uses sound waves (lithotripsy) to break up hard calcium deposits in leg arteries, a condition called peripheral artery disease. About 75 adults with moderate to severe symptoms will receive the treatment. The goal is to see if the device safely opens the arteries enough to restore blood flow.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a device that uses sound waves (lithotripsy) to break up calcium deposits in leg arteries
What this could lead to
If successful, this could offer a safer, more effective way to open hardened leg arteries without major surgery.
What could go wrong
This is an early-stage study with only 75 participants, so results may not apply to everyone. Risks include artery damage or blockages.

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

75 people

The number who actually took part.

Started

Jun 2023

Finished

Apr 2025

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.

General Inclusion Criteria 1. Age of subject is ≥ 18 years. 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. Estimated life expectancy \> 1 year. 5. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s). Angiographic Inclusion Criteria 6. One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs. 7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate. 8. Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate. 9. Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone. 10. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length. General Exclusion Criteria 1. Rutherford Clinical Category 0, 1 and 6 (target limb). 2. History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure, with the exception of toe amputation. Note: inflow treatment of non-target lesions is allowed providing successful treatment. 3. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 4. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 5. Subject has known allergy to urethane, nylon, or silicone. 6. Myocardial infarction within 60 days prior to enrollment. 7. History of stroke within 60 days prior to enrollment. 8. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy. 9. Subject is pregnant or nursing. 10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 11. 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. 12. Covid-19 diagnosis within 30 days. 13. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure. 14. Planned major amputation of target limb. 15. Acute limb ischemia. 16. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot). 17. Subject already enrolled into this study. Angiographic Exclusion Criteria 18. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as ≤30% residual stenosis with no serious angiographic complications (e.g. embolism). 19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism). 20. Target lesion includes in-stent restenosis. 21. Evidence of aneurysm or thrombus in target vessel. 22. No calcium or mild calcium in the target lesion. 23. Target lesion within native or synthetic vessel grafts. 24. 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 arterial disease

Contacts and locations

Locations

  • Advanced Heart and Vein Center

    Thornton, Colorado, 80023, United States

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin, 53211, United States

  • Ascension St. John Jane Phillips Hosptial

    Bartlesville, Oklahoma, 74006, United States

  • Cardiovascular Medicine PC

    Davenport, Iowa, 52803, United States

  • Charlotte Radiology

    Charlotte, North Carolina, 28202, United States

  • HCA Florida Blake Hospital

    Bradenton, Florida, 34209, United States

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19096, United States

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449, United States

  • MedStar Montgomery Medical Center

    Olney, Maryland, 20832, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Sentara Vascular Specialists

    Norfolk, Virginia, 23507, United States

  • Southcoast Hospitals Group

    New Bedford, Massachusetts, 02740, United States

  • Stanford Hospital and Clinics (SHC)

    Palo Alto, California, 94304, United States

  • Tallahassee Memorial Healthcare, Inc.

    Tallahassee, Florida, 32308, United States

  • The Heart Hospital Baylor

    Plano, Texas, 75093, United States

  • The Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • UnityPoint Health Trinity Bettendorf Hospital

    Bettendorf, Iowa, 52722, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

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