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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Coronary Artery Calcification
• Interventions: Device: Intravascular lithotripsy

• Registration Number: NCT06181240
• Lead Sponsor: Bolt Medical

Brief Summary

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 Timeline

• Study Start: 2023-11-17
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-02-20
• Study Completion: 2028-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bolt IVL System	Intravascular lithotripsy	Lithotripsy is a medical procedure that uses shock waves to modify intravascular calcium.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	Within 30 days following procedure	Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.
Primary Effectiveness Endpoint	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.

Secondary Outcome Measures

Name	Time	Method
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	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).
Angiographic success (at <50%)	Immediately after the intervention/procedure/surgery	Stent delivery with \<50% final residual stenosis and without serious angiographic complications.
Device success	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.
MACE	within 6, 12, and 24 months.	MACE within 6, 12, and 24 months.
Procedural success	Immediately after the intervention/procedure/surgery	Stent delivery with a final residual stenosis ≤30% and without in-hospital MACE.
Angiographic success (at ≤30%)	Immediately after the intervention/procedure/surgery	Stent delivery with ≤30% final residual stenosis and without serious angiographic complications.
Serious angiographic complications	Immediately after the intervention/procedure/surgery	Severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Target lesion failure (TLF)	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.

Trial Locations

Locations (27)

Scripps Health; 🇺🇸 La Jolla, California, United States

Trinity Health Michigan Heart; 🇺🇸 Ypsilanti, Michigan, United States

The Icahn School of Medicine at Mt. Sinai; 🇺🇸 New York, New York, United States

HCA Florida Largo Hospital; 🇺🇸 Largo, Florida, United States

Riverside Community Hospital; 🇺🇸 Riverside, California, United States

Nyph/Cuimc; 🇺🇸 New York, New York, United States

HCA FL Memorial Hospital; 🇺🇸 Jacksonville, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

North Mississippi Medical Center; 🇺🇸 Tupelo, Mississippi, United States

Methodist Healthcare Methodist Research Institute; 🇺🇸 San Antonio, Texas, United States

Chippenham Johnson Willis Hospital; 🇺🇸 Richmond, Virginia, United States

Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis; 🇧🇪 Aalst, Belgium

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Tristar Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Segeberger Kliniken GmbH,; 🇩🇪 Bad Segeberg, Germany

SJG St. Paulus GmbH, St.-Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Germany

Cellitinnen Krankenhaus St. Vinzenz; 🇩🇪 Köln, 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