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Heart artery showdown: shockwave or cutting balloon before stenting?

NCT ID NCT06089135

Disease control Sponsor: Baim Institute for Clinical Research 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested two methods to prepare hardened (calcified) heart arteries before placing a stent: a cutting balloon and a shockwave device. About 413 adults with moderate to severe artery hardening took part. The goal was to see which method helps the stent fit better and work more effectively.

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

413 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 2025

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

21 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\. Subject is \> 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria 1. The target lesion is a de novo native coronary lesion 2. The target vessel is a native coronary artery with either: 1. A stenosis \> 70%; or, 2. A stenosis \> 50% and \<70% with evidence of ischemia via either positive stress test, FFR value \< 0.80 or RFR/iFR/DFR value \< 0.89 3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site 4. The target lesion has evidence of significant calcium at the lesion site defined either as, 1. The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography 2. the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium Exclusion Criteria: <!-- --> 1. Patient is pregnant 2. Patient is actively participating in another clinical trial 3. Known LVEF \< 25% 4. Ongoing Non-STEMI with rising biomarkers 5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support 6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment only 7. Patient has a known allergy to contrast which cannot be adequately pre-treated 8. Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed 9. Patient presents with STEMI 10. Patient is unable to tolerate dual anti-platelet therapy 11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days Angiographic Exclusion Criteria <!-- --> 1. Presence of large thrombus in the target vessel 2. Inability to pass coronary guidewire across the lesion 3. The target vessel has excessive tortuosity (Defined as presence of 2+ bends \> 90o or 3+ bends \> 75o) or other anatomic considerations that precludes intravascular imaging 4. The target lesion is within a coronary artery bypass graft 5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification 6. Coronary artery disease that requires surgical revascularization 7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization 8. Investigator feels there is not equipoise regarding the treatment strategy

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Conditions

The condition(s) this trial relates to.

coronary atherosclerosis

As listed by the trial registrant

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

Treatment in calcified coronary disease

Contacts and locations

Locations

  • Banner Health

    Phoenix, Arizona, 85012, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Baylor Scott and White Health

    Plano, Texas, 75024, United States

  • Beth Israel Deaconess Medcial Center

    Boston, Massachusetts, 02215, United States

  • Capital Cardiology

    Albany, New York, 12211, United States

  • Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Columbia Cardiology

    New York, New York, 10032, United States

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, New York, 10032, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Honor Health

    Scottsdale, Arizona, 13400, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115, United States

  • Saint Luke's

    Overland Park, Kansas, 66207, United States

  • UAB Structural Heart and Valve Clinic

    Birmingham, Alabama, 35233, United States

  • UCSF Cardiology

    San Francisco, California, 94117, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • UVA Heart and Vascular Center

    Charlottesville, Virginia, 22903, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wellspan York Hospital

    York, Pennsylvania, 17403, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06510, United States

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