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

July 13, 2026 updated by: Bolt Medical
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
426

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Germany
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH,
      • Cologne, Germany, 50733
        • Cellitinnen Krankenhaus St. Vinzenz
      • Dortmund, Germany, 44137
        • SJG St. Paulus GmbH, St.-Johannes-Hospital Dortmund
  • Lithuania
      • Klaipėda, Lithuania, 92288
        • Klaipeda university hospital
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam University Medical Center
      • Rotterdam, Netherlands
        • Erasmus Medical Center
  • United Kingdom
      • Harefield, United Kingdom, UB9 6JH
        • Harefield Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • London, United Kingdom, SW17 0RE
        • St George's University of London
      • London, United Kingdom, NW3 2AG
        • Royal Free Hospital
  • United States
    • California
      • La Jolla, California, United States, 92121
        • Scripps Health
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Heart Institute
      • Riverside, California, United States, 92501
        • Riverside Community Hospital
      • San Diego, California, United States, 92123
        • Southern California Permanente Medical Gp. / Kaiser Permanente
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital & Medical Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Florida
      • Bradenton, Florida, United States, 34208
        • Nova Clinical Research Centers/Manatee Memorial Hospital
      • Gainesville, Florida, United States, 32605
        • The Cardiac & Vascular Institute
      • Jacksonville, Florida, United States, 32216
        • HCA FL Memorial Hospital
      • Largo, Florida, United States, 33770
        • HCA Florida Largo Hospital
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Hiram, Georgia, United States, 30141
        • Wellstar Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 021114
        • Brigham and Women's Hospital
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health Michigan Heart
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Metropolitan Heart and Vascular Institute
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Saint Luke's Hospital of Kansas City
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • New York
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • New York, New York, United States, 10029
        • The Icahn School of Medicine at Mt. Sinai
      • New York, New York, United States, 10032
        • NYPH/CUIMC
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart Institute
    • Pennsylvania
      • York, Pennsylvania, United States, 10403
        • WellSpan York Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart Research
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare Methodist Research Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Health
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Chippenham Johnson Willis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bolt IVL System
Lithotripsy is a medical procedure that uses shock waves to modify intravascular calcium.
Device: Intravascular lithotripsy
Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: Within 30 days following procedure
Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.
Within 30 days following procedure
Primary Effectiveness Endpoint
Time Frame: Immediately after the intervention/procedure/surgery
Procedural success defined as successful stent delivery with a final residual stenosis <50% (assessed by angiographic core laboratory) and freedom from in-hospital MACE.
Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: Immediately after the intervention/procedure/surgery
The ability to deliver the Bolt IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.
Immediately after the intervention/procedure/surgery
Angiographic success (at <50%)
Time Frame: Immediately after the intervention/procedure/surgery
Stent delivery with <50% final residual stenosis and without serious angiographic complications.
Immediately after the intervention/procedure/surgery
Procedural success
Time Frame: Immediately after the intervention/procedure/surgery
Stent delivery with a final residual stenosis ≤30% and without in-hospital MACE.
Immediately after the intervention/procedure/surgery
Angiographic success (at ≤30%)
Time Frame: Immediately after the intervention/procedure/surgery
Stent delivery with ≤30% final residual stenosis and without serious angiographic complications.
Immediately after the intervention/procedure/surgery
Serious angiographic complications
Time Frame: Immediately after the intervention/procedure/surgery
Severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Immediately after the intervention/procedure/surgery
MACE
Time Frame: within 6, 12, and 24 months.
MACE within 6, 12, and 24 months.
within 6, 12, and 24 months.
Target lesion failure (TLF)
Time Frame: 30 days, 6 months, 12 months, and 24 months
Cardiac death, target vessel myocardial infarction (TV-MI) (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods at 30 days, 6 months, 12 months, and 24 months.
30 days, 6 months, 12 months, and 24 months
All deaths, cardiac deaths, MIs, TV-MIs, procedural and nonprocedural MIs, ID-TVRs, ID-TLRs, non-ID-TLRs, non-ID-TVRs, all revascularizations (ID and non-ID), and stent thrombosis
Time Frame: Periprocedure, within 30 days, 6 months, 12 months, and 24 months
All deaths, cardiac deaths, MIs, TV-MIs, procedural and nonprocedural MIs, ID-TVRs, ID-TLRs, non-ID-TLRs, non-ID-TVRs, all revascularizations (ID and non-ID), and stent thrombosis (Academic Research Consortium (ARC) definite, probable, definite or probable).
Periprocedure, within 30 days, 6 months, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bolt Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margaret McEntegart, MD, PhD, NY Presbyterian Hospital/Columbia University Medical Center
  • Principal Investigator: Nicholas van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-005614

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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