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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Calcification
• Intervention / Treatment: Device: Intravascular lithotripsy

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: Interventional
• Enrollment (Actual): 426
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the intervention/procedure/surgery
Angiographic success (at <50%)	Stent delivery with <50% final residual stenosis and without serious angiographic complications.	Immediately after the intervention/procedure/surgery
Procedural success	Stent delivery with a final residual stenosis ≤30% and without in-hospital MACE.	Immediately after the intervention/procedure/surgery
Angiographic success (at ≤30%)	Stent delivery with ≤30% final residual stenosis and without serious angiographic complications.	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.	Immediately after the intervention/procedure/surgery
MACE	MACE within 6, 12, and 24 months.	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.	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).	Periprocedure, within 30 days, 6 months, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: Bolt Medical
• Investigators: 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

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): February 5, 2026
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CAD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID 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