Coronary Artery DiseaseFRACTURENCT06181240
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
A study testing Intravascular lithotripsy in people with Coronary Artery Disease and Coronary Artery Calcification, run by Bolt Medical at 46 sites in 7 countries.
Trial summary
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Calcification
- What is being tested?
- Intravascular lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 46 sitesin 7 countries
- Study dates
- 19 Jan 2024to 20 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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;
Trial locations and contacts
46 sites in 7 countries.
46 sites in 7 countries
United States31 sites
Austin Heart Research
Austin, Texas, 78756
Brigham and Women's Hospital
Boston, Massachusetts, 021114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nova Clinical Research Centers/Manatee Memorial Hospital
Bradenton, Florida, 34208
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, 55433
The Cardiac & Vascular Institute
Gainesville, Florida, 32605
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Wellstar Research Institute
Hiram, Georgia, 30141
HCA FL Memorial Hospital
Jacksonville, Florida, 32216
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64131
Scripps Health
La Jolla, California, 92121
HCA Florida Largo Hospital
Largo, Florida, 33770
Cedars-Sinai Heart Institute
Los Angeles, California, 90048
Medical Center of the Rockies
Loveland, Colorado, 80538
Intermountain Health
Murray, Utah, 84107
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
The Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Nyph/Cuimc
New York, New York, 10032
The Valley Hospital
Paramus, New Jersey, 07652
Providence Heart Institute
Portland, Oregon, 97225
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Chippenham Johnson Willis Hospital
Richmond, Virginia, 23235
Riverside Community Hospital
Riverside, California, 92501
Methodist Healthcare Methodist Research Institute
San Antonio, Texas, 78229
Southern California Permanente Medical Gp. / Kaiser Permanente
San Diego, California, 92123
Montefiore Medical Center
The Bronx, New York, 10467
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Wellspan York Hospital
York, Pennsylvania, 10403
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
United Kingdom6 sites
Harefield Hospital
Harefield, UB9 6JH
Royal Free Hospital
London, NW3 2AG
St. Thomas' Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
St George's University of London
London, SW17 0RE
Royal Brompton Hospital
London, SW3 6NP
Germany3 sites
Segeberger Kliniken GmbH,
Bad Segeberg, 23795
Cellitinnen Krankenhaus St. Vinzenz
Cologne, 50733
SJG St. Paulus GmbH, St.-Johannes-Hospital Dortmund
Dortmund, 44137
Lithuania2 sites
Klaipeda University Hospital
Klaipėda, 92288
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Netherlands2 sites
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Erasmus Medical Center
Rotterdam
About this study
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
Read the 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.
- Being tested
- Intravascular lithotripsy
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsyDevice
Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.
| Study group | Role | What they receive |
|---|---|---|
| Bolt IVL System | Experimental | Lithotripsy is a medical procedure that uses shock waves to modify intravascular calcium. Receives: Device: Intravascular lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.
Measured: Within 30 days following procedure
Primary Effectiveness Endpoint
Procedural success defined as successful stent delivery with a final residual stenosis <50% (assessed by angiographic core laboratory) and freedom from in-hospital MACE.
Measured: Immediately after the intervention/procedure/surgery
Secondary outcomes (8)
Device success
The ability to deliver the Bolt IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.
Measured: Immediately after the intervention/procedure/surgery
Angiographic success (at <50%)
Stent delivery with <50% final residual stenosis and without serious angiographic complications.
Measured: Immediately after the intervention/procedure/surgery
Procedural success
Stent delivery with a final residual stenosis ≤30% and without in-hospital MACE.
Measured: Immediately after the intervention/procedure/surgery
Angiographic success (at ≤30%)
Stent delivery with ≤30% final residual stenosis and without serious angiographic complications.
Measured: Immediately after the intervention/procedure/surgery
Serious angiographic complications
Severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Measured: Immediately after the intervention/procedure/surgery
MACE
MACE within 6, 12, and 24 months.
Measured: within 6, 12, and 24 months.
Target lesion failure (TLF)
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.
Measured: 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
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).
Measured: Periprocedure, within 30 days, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start19 Jan 2024
- Primary completion5 Feb 2026
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, single-arm, multicenter, interventional study in adults (≥18 years of age) with de novo, calcified, stenotic coronary artery lesions.
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolt Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret McEntegart, MD, PhD, Principal investigator, NY Presbyterian Hospital/Columbia University Medical CenterNicholas van Mieghem, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181240
- Sponsor's protocol ID
- CR-005614
- Acronym
- FRACTURE
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McEntegart M, Budrys P, Sharma S, Spratt JC, Nef H, Jefferson B, Verouden N, Corrigan FE 3rd, De Silva K, Chatterjee D, Price M, Webb I, Verreault-Julien L, Sinning JM, Mollmann H, Chambers J, Latib A, Kirtane AJ, Austin B, Meyer TE, TsungYing Tsai J, Cavalcante R, Van Mieghem NM; FRACTURE Investigators. Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study. JACC Cardiovasc Interv. 2026 Oct 26;19(20):2710-2722. doi: 10.1016/j.jcin.2026.08.018.
PubMed 42933913
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
- ClinicalTrials.gov ID
- NCT06181240
- Acronym / sponsor ID
- FRACTURE / CR-005614
- Keywords
- CAD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Bolt MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, single-arm, multicenter, interventional study in adults (≥18 years of age) with de novo, calcified, stenotic coronary artery lesions.
| Arm | Type | Receives |
|---|---|---|
| Bolt IVL System | Experimental | Device: Intravascular lithotripsyLithotripsy is a medical procedure that uses shock waves to modify intravascular calcium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular lithotripsyLithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting. | Device | Bolt IVL System |
Primary outcome
Primary Safety Endpoint
Time frame: Within 30 days following procedure
Freedom from major adverse cardiac events (MACE) within 30 days following the index 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.
8 secondary outcomes
Device success
Time frame: Immediately after the intervention/procedure/surgery
Angiographic success (at <50%)
Time frame: Immediately after the intervention/procedure/surgery
Procedural success
Time frame: Immediately after the intervention/procedure/surgery
Angiographic success (at ≤30%)
Time frame: Immediately after the intervention/procedure/surgery
Serious angiographic complications
Time frame: Immediately after the intervention/procedure/surgery
MACE
Time frame: within 6, 12, and 24 months.
Target lesion failure (TLF)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42933913McEntegart M, Budrys P, Sharma S, Spratt JC, Nef H, Jefferson B, Verouden N, Corrigan FE 3rd, De Silva K, Chatterjee D, Price M, Webb I, Verreault-Julien L, Sinning JM, Mollmann H, Chambers J, Latib A, Kirtane AJ, Austin B, Meyer TE, TsungYing Tsai J, Cavalcante R, Van Mieghem NM; FRACTURE Investigators. Safety and Effectiveness of a Novel Laser-Based Intravascular Lithotripsy System for Coronary Calcium: FRACTURE Study. JACC Cardiovasc Interv. 2026 Oct 26;19(20):2710-2722. doi: 10.1016/j.jcin.2026.08.018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McEntegart, MD, PhD principal investigator
NY Presbyterian Hospital/Columbia University Medical Center
Nicholas van Mieghem, MD, PhD principal investigator
Erasmus Medical Center
46 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy in people with Coronary Artery Disease and Coronary Artery Calcification, run by Bolt Medical at 46 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, United Kingdom, Germany, Lithuania, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Within 30 days following procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06181240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.