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NCT06181240

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

Sponsor: Bolt Medical

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2024-01-19

Completion Date

2028-03-20

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Coronary Artery Disease Coronary Artery Calcification

Interventions

DEVICE

Intravascular lithotripsy

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

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;

Locations (46)

Scripps Health

La Jolla, California, United States

Cedars-Sinai Heart Institute

Los Angeles, California, United States

Riverside Community Hospital

Riverside, California, United States

Southern California Permanente Medical Gp. / Kaiser Permanente

San Diego, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Nova Clinical Research Centers/Manatee Memorial Hospital

Bradenton, Florida, United States

The Cardiac & Vascular Institute

Gainesville, Florida, United States

HCA FL Memorial Hospital

Jacksonville, Florida, United States

HCA Florida Largo Hospital

Largo, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Wellstar Research Institute

Hiram, Georgia, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Trinity Health Michigan Heart

Ypsilanti, Michigan, United States

Metropolitan Heart and Vascular Institute

Coon Rapids, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

The Valley Hospital

Paramus, New Jersey, United States

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

The Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Nyph/Cuimc

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

Providence Heart Institute

Portland, Oregon, United States

Wellspan York Hospital

York, Pennsylvania, United States

Tristar Centennial Medical Center

Nashville, Tennessee, United States

Austin Heart Research

Austin, Texas, United States

Methodist Healthcare Methodist Research Institute

San Antonio, Texas, United States

Intermountain Health

Murray, Utah, United States

Chippenham Johnson Willis Hospital

Richmond, Virginia, United States

Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis

Aalst, Belgium

Aarhus University Hospital

Aarhus, Denmark

Segeberger Kliniken GmbH,

Bad Segeberg, Germany

Cellitinnen Krankenhaus St. Vinzenz

Cologne, Germany

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

Dortmund, Germany

Klaipeda University Hospital

Klaipėda, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Amsterdam University Medical Center

Amsterdam, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Harefield Hospital

Harefield, United Kingdom

Royal Free Hospital

London, United Kingdom

St. Thomas' Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

St George's University of London

London, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (46)