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Using laser technology to treat coronary artery disease by breaking down calcium deposits

Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

NA · Bolt Medical · NCT06181240

This study is testing a new laser treatment to see if it can break down calcium buildup in the arteries of people with coronary artery disease before they have a balloon procedure to open up their blood vessels.

Quick facts

PhaseNA
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorBolt Medical (industry)
Locations27 sites (La Jolla, California and 26 other locations)
Trial IDNCT06181240 on ClinicalTrials.gov

What this trial studies

The FRACTURE Trial is a multicenter, interventional study that aims to evaluate the effectiveness of the Bolt Intravascular Lithotripsy System in modifying coronary calcium in patients with coronary artery disease. This study involves delivering laser energy to disrupt calcium deposits in the arteries before performing balloon angioplasty at low pressures. It is designed for patients with significant coronary artery stenosis who are candidates for percutaneous coronary intervention. The trial is being conducted at various centers across the US and internationally.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with significant coronary artery disease suitable for percutaneous coronary intervention.

Not a fit: Patients with non-calcified coronary lesions or those not suitable for percutaneous coronary intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the outcomes of patients undergoing treatment for coronary artery disease by enhancing the effectiveness of angioplasty procedures.

How similar studies have performed: While the use of intravascular lithotripsy is a novel approach, similar studies have shown promise in treating calcified lesions in coronary arteries.

Eligibility criteria

Show full inclusion / exclusion criteria 
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;

Where this trial is running

La Jolla, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coronary Artery Disease, Coronary Artery Calcification, CAD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.