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Laser zaps heart calcium to help stents stick

NCT ID NCT06181240

Disease control Sponsor: Bolt Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 3 times

Summary

This study tests a new laser-based device that breaks up calcium deposits in the heart's arteries before placing a stent. About 426 adults with coronary artery disease will receive the treatment. The goal is to see if the device safely improves stent delivery and reduces complications.

What this could mean

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

Active substance
laser-based intravascular lithotripsy device
What this could lead to
If successful, this device could offer a new way to safely treat heavily calcified coronary arteries, potentially improving outcomes for patients needing stents.
What could go wrong
This is an early, single-arm study without a comparison group, so results may not prove superiority over existing treatments. Risks include heart complications during or after the procedure.

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

426 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Mar 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.

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.

Key Inclusion Criteria: * Subject is ≥18 years of age; * Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI); * For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure; * For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN); * Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with: * Stenosis of ≥70% and \<l00%; or * Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.90, or IVUS or OCT minimum lumen area ≤4.0 mm2; * Evidence of calcification at the target lesion site by * angiography, with fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or * Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), with presence of ≥270 degrees of calcium on at least 1 cross section; * Ability to pass a 0.014" guidewire across the lesion. Key Exclusion Criteria: * Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure; * New York Heart Association (NYHA) class III or IV heart failure at time of index procedure; * Prospective need for hemodynamic support, i.e., IABP or Impella; * Chronic kidney disease with serum creatinine \>2.5 mg/dL, eGFR \<30 mL/min/1.73m2, or on chronic dialysis; * Unprotected left main diameter stenosis \>50%; * Target vessel is excessively tortuous defined as the presence of two or more bends \>90º or three or more bends \>75º; * Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion; * Chronic Total Occlusion; * Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft;

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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 calcification Coronary artery disease

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Amsterdam University Medical Center

    Amsterdam, 1105 AZ, Netherlands

  • Austin Heart Research

    Austin, Texas, 78756, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 021114, United States

  • Cedars-Sinai Heart Institute

    Los Angeles, California, 90048, United States

  • Cellitinnen Krankenhaus St. Vinzenz

    Cologne, 50733, Germany

  • Chippenham Johnson Willis Hospital

    Richmond, Virginia, 23235, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • HCA FL Memorial Hospital

    Jacksonville, Florida, 32216, United States

  • HCA Florida Largo Hospital

    Largo, Florida, 33770, United States

  • Harefield Hospital

    Harefield, UB9 6JH, United Kingdom

  • Intermountain Health

    Murray, Utah, 84107, United States

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Klaipeda University Hospital

    Klaipėda, 92288, Lithuania

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California, 91360, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • Methodist Healthcare Methodist Research Institute

    San Antonio, Texas, 78229, United States

  • Metropolitan Heart and Vascular Institute

    Coon Rapids, Minnesota, 55433, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501, United States

  • Nova Clinical Research Centers/Manatee Memorial Hospital

    Bradenton, Florida, 34208, United States

  • Nyph/Cuimc

    New York, New York, 10032, United States

  • Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis

    Aalst, 9300, Belgium

  • Providence Heart Institute

    Portland, Oregon, 97225, United States

  • Riverside Community Hospital

    Riverside, California, 92501, United States

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Free Hospital

    London, NW3 2AG, United Kingdom

  • SJG St. Paulus GmbH, St.-Johannes-Hospital Dortmund

    Dortmund, 44137, Germany

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64131, United States

  • Scripps Health

    La Jolla, California, 92121, United States

  • Segeberger Kliniken GmbH,

    Bad Segeberg, 23795, Germany

  • Southern California Permanente Medical Gp. / Kaiser Permanente

    San Diego, California, 92123, United States

  • St George's University of London

    London, SW17 0RE, United Kingdom

  • St. Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • The Cardiac & Vascular Institute

    Gainesville, Florida, 32605, United States

  • The Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Tristar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661, Lithuania

  • Wellspan York Hospital

    York, Pennsylvania, 10403, United States

  • Wellstar Research Institute

    Hiram, Georgia, 30141, United States

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