RECRUITING

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

Conditions

Coronary Artery Disease Coronary Artery Calcification CAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-11-17

Study Completion:2026-03-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06181240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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;

Inclusion Criteria

Exclusion 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.

* 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;

Contacts and Locations

Study Contact

Timothy E. Meyer, PhD

CONTACT

+1 760-392-3963

timothy@boltmed.com

Anne Hurley

CONTACT

+1 760-392-3958

anne@boltmed.com

Principal Investigator

Margaret McEntegart, MD, PhD

PRINCIPAL_INVESTIGATOR

NY Presbyterian Hospital/Columbia University Medical Center

Nicholas van Mieghem, MD, PhD

PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Study Locations (Sites)

Columbia University Medical Center/NYPH CUMC/NYPH

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Bolt Medical

Margaret McEntegart, MD, PhD, PRINCIPAL_INVESTIGATOR, NY Presbyterian Hospital/Columbia University Medical Center
Nicholas van Mieghem, MD, PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17

Study Completion Date2026-03-20

Study Record Updates

Study Start Date2023-11-17

Study Completion Date2026-03-20

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Coronary Artery Disease
Coronary Artery Calcification