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New device uses sound waves to crack heart artery calcium

NCT ID NCT07407738

Disease control Sponsor: Shunmei Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 4 times

Summary

This study tests a new device called ShockFast IVL against an existing one, ShockWave IVL, for treating hardened calcium deposits in heart arteries. Both devices use sound waves to break up calcium so a stent can be placed more easily. The trial will involve 120 adults with coronary artery disease who need a stent, and it will measure how well the stent opens the artery.

What this could mean

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

Active substance
ShockFast IVL device (intravascular lithotripsy)
What this could lead to
If it works, this could offer a new, effective option for breaking up calcium in heart arteries, making stent placement safer and more successful.
What could go wrong
This is a small, early-stage trial with only 120 participants, and it compares a new device to an existing one. The new device may not work as well or could have unexpected risks.

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 120 people

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

Started

Feb 2026

Expected to finish

Mar 2027

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.

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. Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing Angiographic criteria: 2. Native de novo coronary lesions 3. Vessel diameter between 2.5mm - 4.0mm 4. Lesion Length: ≤40mm 5. Severe Calcification: 1. Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other 2. Presence of severe calcified protruding noduli 6. No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \[TIMI\] 3 flow at baseline) 7. Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia OCT Criteria: 8. Total calcium arc \> 180° or 9. Presence of a protruding calcified noduli Exclusion Criteria: 1. Ejection fraction less than 25% 2. Lesion located in Left Main (LM) coronary artery 3. Calcifications located mostly \> 0.5 mm from the vessel lumen. 4. Severe renal Impairment; Serum Creatinine \> 220 μmol or currently undergoing hemodialysis 5. Severe lesion tortuosity where OCT is judged impossible to cross. 6. Inability to tolerate dual antiplatelet therapy for 6 months or longer 7. Inability to obtain inform consent or deemed poorly compliant by the investigator 8. Presence of permanent pacemaker 9. Angiographic evidence of thrombus in the target vessel 10. Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX) 11. Target lesion is a chronic total occlusion (CTO) 12. Presence of aneurysm within 10mm proximal or distal to the target lesion

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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.

Calcified coronary artery disease Coronary arterial disease

How to take part

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

  1. The places running it

    12 sites in 4 countries. 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

  • Centre Cardiologique du Nord

    RECRUITING

    Paris, France

  • Centre Hospitalier de Valenciennes

    NOT_YET_RECRUITING

    Valenciennes, France

  • Infirmerie Protestante de Lyon

    RECRUITING

    Lyon, France

  • La Paz University Hospital

    RECRUITING

    Madrid, Spain

  • La Princesa Univeristy Hospital

    ACTIVE_NOT_RECRUITING

    Madrid, Spain

  • MediClin Heart Center Lahr

    NOT_YET_RECRUITING

    Lahr, Germany

  • Medical University of Silesia

    NOT_YET_RECRUITING

    Katowice, Poland

  • Miedziowe Centrum Zdrowia

    RECRUITING

    Lubin, Poland

  • Regional Specialist Hospital

    RECRUITING

    Wroclaw, Poland

  • Segeberger Kliniken GMBH / Herz- und Gefäßzentrum

    NOT_YET_RECRUITING

    Bad Segeberg, Germany

  • University Hospital Krakow

    NOT_YET_RECRUITING

    Krakow, Poland

  • Virgen Arrixaca University Clinical Hospital

    RECRUITING

    Murcia, Spain

  • Virgen del Rocío University Hospital

    RECRUITING

    Seville, Spain

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