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Sound wave device aims to improve heart stent success in women

NCT ID NCT05755711

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 (intravascular lithotripsy) to break up hard calcium deposits in the heart arteries of women with coronary artery disease. The goal is to make it easier to place stents and improve outcomes. About 400 women are being followed to see if the device is safe and effective in real-world use.

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 Coronary IVL System (a device that uses sound waves to break up calcium in heart arteries)
What this could lead to
If successful, this could show that the device helps women with calcified heart disease get better stent placement and fewer complications.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove the device is better than other treatments. It only includes women, so findings may not apply to men.

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

399 people

The number who actually took part.

Started

May 2023

Expected to finish

Apr 2028

An estimate. End dates often move.

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.

Who is studied

Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.

Ages

18 years and older

Sex

Female participants only

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: 1. The subject is a non-pregnant female ≥18 years of age 2. The subject meets indications for PCI and stent 3. The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion 4. The subject is willing to comply with protocol-specified follow-up evaluations 5. The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC) Exclusion Criteria: 1. Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year 2. Subjects presenting with cardiogenic shock at the time of the index procedure 3. Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow 4. Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines 5. Subject is enrolled in any study of an investigational device or drug that may interfere with study results

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • AP-HP Hopital Pitie-Salpetriere

    Paris, Paris, 75013, France

  • Baylor Scott & White Research Institute

    Plano, Texas, 75093, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Centennial Heart

    Nashville, Tennessee, 37203, United States

  • Centre Hospitalier d'Antibes

    Antibes, Antibes, 06606, France

  • Clinique Pasteur

    Toulouse, BP 27617, 31076 Cedex 3, France

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • DHR Health Heart Institute

    McAllen, Texas, 78503, United States

  • Emory Hospital

    Atlanta, Georgia, 30308, United States

  • Golden Jubilee National Hospital

    Clydebank, G81 4HX, United Kingdom

  • Good Samaritan Hospital

    Los Angeles, California, 90017, United States

  • Hammersmith Hospital

    London, W12 0HS,, United Kingdom

  • Heart and Lung Center Leipzig

    Leipzig, Germany

  • Hospital Clinico De Santiago

    Santiago de Compostela, A Coruña, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

  • Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier

    Massy, 91300, France

  • Kaiser Permanente - San Francisco Medical Center

    San Francisco, California, 94118, United States

  • Krankenhaus der Barmherzigen Bruder Trier

    Trier, Nordallee 1, 54292, Germany

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE, United Kingdom

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • MUSC Health University Medical Center

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • NYU Langone Health

    Brooklyn, New York, 11220, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New England Heart and Vascular Institute

    Manchester, New Hampshire, 03102, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Overlake Medical Center

    Bellevue, Washington, 98004, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • South Denver Cardiology Associates, P.C

    Littleton, Colorado, 80120, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. George's Hospital

    London, SW17 0QT, United Kingdom

  • Stanford University

    Stanford, California, 94305, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy

    Cincinnati, Ohio, 45219, United States

  • Tulane University Center for Clinical Research

    New Orleans, Louisiana, 70112, United States

  • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

    Mainz, Langenbeckstr. 1, 55131, Germany

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17403, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.