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

Launched by BOLT MEDICAL · Dec 12, 2023

Keywords

ClinConnect Summary

The FRACTURE Trial is a research study designed to explore a new treatment for people with coronary artery disease, which is a condition where the arteries that supply blood to the heart become narrowed or blocked, often due to calcium buildup. This trial aims to see how effective a special laser treatment, called intravascular lithotripsy, is in reducing this calcium in the arteries to improve blood flow. The study is currently recruiting participants aged 18 and older, who have certain types of coronary artery disease that make them suitable for a procedure called Percutaneous Coronary Intervention (PCI).

To participate in the trial, individuals must meet specific criteria, such as having a significant blockage in their coronary arteries (at least 50% narrowed) and evidence of calcium at the blockage site. Participants will undergo the laser treatment, and their progress will be monitored throughout the study. It’s important to note that some individuals, like those who recently had a heart attack or have severe heart failure, may not be eligible for this trial. Overall, this study hopes to provide valuable insights into improving treatments for coronary artery disease.

Gender

ALL

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;