Clinical trial NCT06181240: Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
Official title: Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Calcification
Keywords: CAD
Lead sponsor: Bolt Medical
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, single-arm, multicenter, interventional study in adults (≥18 years of age) with de novo, calcified, stenotic coronary artery lesions.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Within 30 days following procedure
measure: Primary Effectiveness Endpoint
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Device success
timeFrame: Immediately after the intervention/procedure/surgery
measure: Angiographic success (at <50%)
timeFrame: Immediately after the intervention/procedure/surgery
measure: Procedural success
timeFrame: Immediately after the intervention/procedure/surgery
measure: Angiographic success (at ≤30%)
timeFrame: Immediately after the intervention/procedure/surgery
measure: Serious angiographic complications
timeFrame: Immediately after the intervention/procedure/surgery
measure: MACE
timeFrame: within 6, 12, and 24 months.
measure: Target lesion failure (TLF)
timeFrame: 30 days, 6 months, 12 months, and 24 months
measure: 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
timeFrame: Periprocedure, within 30 days, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Jacksonville
country: United States
facility: HCA FL Memorial Hospital
state: Florida
city: Largo
country: United States
facility: HCA Florida Largo Hospital
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: Trinity Health Michigan Heart
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: The Icahn School of Medicine at Mt. Sinai
state: New York
city: New York
country: United States
facility: Nyph/Cuimc
state: New York
city: Nashville
country: United States
facility: Tristar Centennial Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Healthcare Methodist Research Institute
state: Texas
city: Richmond
country: United States
facility: Chippenham Johnson Willis Hospital
state: Virginia
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis, afgekort OLV ziekenhuis
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH,
city: Dortmund
country: Germany
facility: SJG St. Paulus GmbH, St.-Johannes-Hospital Dortmund
city: Köln
country: Germany
facility: Cellitinnen Krankenhaus St. Vinzenz
city: Klaipėda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Harefield
country: United Kingdom
facility: Harefield Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's University of London
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: NY Presbyterian Hospital/Columbia University Medical Center
name: Margaret McEntegart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Nicholas van Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: