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Sound waves smash heart artery calcium in new french study

NCT ID NCT05113407

Disease control Sponsor: French Cardiology Society 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tracks 1000 patients in France who receive a special device that uses sound waves to crack calcium deposits in heart arteries before placing a stent. The goal is to see if the device is safe and works well in everyday practice. Researchers will check for heart-related problems like death, heart attack, or need for another procedure one year later.

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 C2 Coronary Lithotripsy System (a device that uses sound waves to break up calcium in heart arteries before placing a stent)
What this could lead to
If successful, this could show that the Shockwave C2 system is a safe and effective way to treat hardened heart arteries, potentially improving outcomes for patients with calcified blockages.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device may not work for all patients, and risks include heart attack, need for repeat procedures, or death.

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 1,000 people

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

Started

Nov 2021

Expected to finish

Sep 2027

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

Patients will be included in cardiology departments participating in the study. The study may be offered to any patient undergoing coronary artery angioplasty using the Shockwave Medical C2 coronary lithotripsy system.

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 over 18 years old * Patient affiliated to the National Health Insurance System * Patient for whom a coronary angioplasty procedure is performed using the Shockwave Medical C2 Coronary Lithotripsy System * For indications of stent malexpansions, stent malexpansion must be defined by: a) angiography: stent malexpansion \>30% (QCA and/or stent magnification) b) endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) \<4.5 mm2 or a ratio of MSA/MLA on reference segment\<0.8 * Patient willing to participate in the registry Exclusion Criteria: * Patient under 18 years of age * Pregnant or breastfeeding patient * Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or legal guardianship)

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As listed by the trial registrant

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

Angioplasty Coronary balloon Lithotripsy

Contacts and locations

Locations

  • Clinique Pasteur

    Toulouse, France

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