Resumen

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

Edad: 18 años o más

Género: Todos

Fecha de inicio: 01/19/2024

Fecha de finalización principal (estimada): 02/05/2026

Fecha estimada de finalización del estudio: 03/20/2028

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

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.

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

Criterios clave de inclusión:

* 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 \

* 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.

Criterios de exclusión clave:

* 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;