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Sound waves smash heart artery calcium in new trial

NCT ID NCT07512206

Disease control Sponsor: OPCI Core Laboratories LLC 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called the Shockwave C2 Aero, which uses sound waves to break up calcium deposits in heart arteries before placing a stent. About 200 people with coronary artery disease will be enrolled across 8 U.S. sites. The goal is to see if the device works safely and effectively in real-world settings.

What this could mean

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

Active substance
Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System (a device that uses sound waves to break up calcium in heart arteries)
What this could lead to
If successful, this device could offer a safer, more effective way to treat heavily calcified coronary arteries, potentially reducing complications and improving long-term heart health.
What could go wrong
This is a small, early-stage study (200 people) without a comparison group, so results may not apply to everyone. Risks include artery damage, heart attack, or the device failing to work as intended.

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

About 200 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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.

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: 1. Age ≥18 years 2. Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease 3. Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care 4. Ability to provide informed consent 5. Willingness and ability to comply with study follow-up requirements Exclusion Criteria: 1. ST-elevation myocardial infarction (STEMI) at presentation 2. Cardiogenic shock at time of procedure 3. In-stent restenosis (ISR) target lesion 4. Known contraindication to antiplatelet or anticoagulation therapy 5. Known intolerance or contraindication to contrast media not amenable to premedication 6. Participation in another investigational drug or device study that could interfere with the endpoints of this study 7. Life expectancy \<1 year 8. Inability or unwillingness to comply with study procedures or follow-up

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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 (CAD) Coronary calcification Coronary calcified disease Coronary calcified nodules

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White Health - The Heart Hospital Plano

    Plano, Texas, 75093, United States

  • Good Samaritan University Hospital

    West Islip, New York, 11795, United States

  • Henry Ford St. John Hospital

    Detroit, Michigan, 48236, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • St Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • WellSpan Health, York Hospital

    York, Pennsylvania, 17403, United States

More trials for these conditions

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