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Sound waves to the rescue: new device aims to heal legs and prevent amputation

NCT ID NCT06149650

Disease control Sponsor: Cardiovascular and Interventional Radiological Society of Europe 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study is testing a device that uses sound waves to break up calcium buildup in leg arteries of people with chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease. Researchers will track 400 patients to see if the treatment helps wounds heal and prevents amputation. The goal is to gather real-world evidence on how well this approach works.

What this could mean

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

Active substance
Shockwave Medical IVL System (a device that uses sound waves to break up calcium in leg arteries)
What this could lead to
If successful, this could show that the shockwave device helps heal leg wounds and reduces the need for amputation in people with severe blocked leg arteries.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the device works better than other treatments. Results may not apply to all patients.

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.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.

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: * Patient with chronic limb-threatening ischemia (Rutherford Category ≥4) * Femoropopliteal and/or crural calcified lesions visible on fluoroscopy; * Treatment with IVl using the Shockwave Medical IVL System. Exclusion Criteria: * \< 18 years old; * Incapacity or refusal to give informed consent; * Ongoing pregnancy; * Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

Chronic limb-threatening ischemia

Contacts and locations

Locations

  • Bedfordshire Hospitals NHS Foundation Trust

    Bedford, MK42 9DJ, United Kingdom

  • CHU François Mitterrand

    Dijon, 21000, France

  • Ente Ospedaliero Cantonale

    Lugano, 6500, Switzerland

  • Evangelisches Krankenhaus

    Mülheim, 45468, Germany

  • Friedrich Ebert Krankenhaus

    Neumünster, 24534, Germany

  • Frimley Health NHS Foundation Trust

    Frimley, GU16 7UJ, United Kingdom

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital General de Granollers

    Granollers, 08402, Spain

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ, United Kingdom

  • Hôpital Sacré Coeur de Montréal

    Montreal, H4J 1C5, Canada

  • Imperial College Healthcare NHS Trust

    London, W2 1NY, United Kingdom

  • Institute Mutualiste Montsouris

    Paris, 75014, France

  • KRH Klinikum Robert Koch Gehrden

    Hanover, 30989, Germany

  • Kantonsspital Winterthur

    Winterthur, 8400, Switzerland

  • Klinik Florisdorf

    Vienna, 1210, Austria

  • Klinik Hietzing

    Vienna, 1130, Austria

  • Krankenhaus Barmherzige Brüder Linz

    Linz, 4020, Austria

  • Krankenhaus der Barmherzigen Brüder

    Eisenstadt, 7000, Austria

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX, United Kingdom

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP, United Kingdom

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • Medizinische Universität Graz

    Graz, 8036, Austria

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE1 4LP, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU, United Kingdom

  • Rhéna Clinique de Strasbourg

    Strasbourg, 67000, France

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • SLK-Heilbronn

    Heilbronn, 74078, Germany

  • Schön Klinik Rendsburg

    Rendsburg, 24768, Germany

  • Semmelweis University

    Budapest, 1085, Hungary

  • Sheffield Teaching Hospitals NHS FT

    Sheffield, S10 2JF, United Kingdom

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • St Marien-Krankenhaus

    Siegen, 57072, Germany

  • Städtisches Klinikum

    Karlsruhe, 76133, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • University of Navarra

    Pamplona, 31006, Spain

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsmedizin Essen

    Essen, 45147, Germany

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