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

NCT06181240 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CR-005614
• Study Type: interventional
• Target: 426
• Locations: 7 countries
• Sites: 46

Brief Summary

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Conditions

Coronary Artery Disease; Coronary Artery Calcification

Keywords

CAD

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.

  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.

  Immediately after the intervention/procedure/surgery

Secondary Outcomes (8)

• Device success

  Immediately after the intervention/procedure/surgery

• Angiographic success (at <50%)

  Immediately after the intervention/procedure/surgery

• Procedural success

  Immediately after the intervention/procedure/surgery

• Angiographic success (at ≤30%)

  Immediately after the intervention/procedure/surgery

• Serious angiographic complications

  Immediately after the intervention/procedure/surgery

Study Arms (1)

Bolt IVL System

EXPERIMENTAL

Lithotripsy is a medical procedure that uses shock waves to modify intravascular calcium.

Device: Intravascular lithotripsy

Interventions

Intravascular lithotripsy DEVICE

Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.

Bolt IVL System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bolt Medical: lead

Study Sites (46)

Scripps Health

La Jolla, California, 92121, United States

Location

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

Riverside Community Hospital

Riverside, California, 92501, United States

Location

Southern California Permanente Medical Gp. / Kaiser Permanente

San Diego, California, 92123, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Nova Clinical Research Centers/Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

The Cardiac & Vascular Institute

Gainesville, Florida, 32605, United States

Location

HCA FL Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

HCA Florida Largo Hospital

Largo, Florida, 33770, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Wellstar Research Institute

Hiram, Georgia, 30141, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 021114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Trinity Health Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Metropolitan Heart and Vascular Institute

Coon Rapids, Minnesota, 55433, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64131, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

The Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Nyph/Cuimc

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Providence Heart Institute

Portland, Oregon, 97225, United States

Location

Wellspan York Hospital

York, Pennsylvania, 10403, United States

Location

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Austin Heart Research

Austin, Texas, 78756, United States

Location

Methodist Healthcare Methodist Research Institute

San Antonio, Texas, 78229, United States

Location

Intermountain Health

Murray, Utah, 84107, United States

Location

Chippenham Johnson Willis Hospital

Richmond, Virginia, 23235, United States

Location

Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis

Aalst, 9300, Belgium

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Segeberger Kliniken GmbH,

Bad Segeberg, 23795, Germany

Location

Cellitinnen Krankenhaus St. Vinzenz

Cologne, 50733, Germany

Location

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

Dortmund, 44137, Germany

Location

Klaipeda University Hospital

Klaipėda, 92288, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Harefield Hospital

Harefield, UB9 6JH, United Kingdom

Location

Royal Free Hospital

London, NW3 2AG, United Kingdom

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

St George's University of London

London, SW17 0RE, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Margaret McEntegart, MD, PhD

  NY Presbyterian Hospital/Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

• Nicholas van Mieghem, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, single-arm, multicenter, interventional study in adults (≥18 years of age) with de novo, calcified, stenotic coronary artery lesions.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 26, 2023
• Study Start: January 19, 2024
• Primary Completion: February 5, 2026
• Study Completion (Estimated): March 20, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

DK (1); LI (2); BE (1); US (31); DE (3); NL (2); GB (6)