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

Key Inclusion Criteria:

• Subject is ≥18 years of age;

• Subjects with native coronary artery disease (including stable or unstable anginaand 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 limitof 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 ofthe study procedure from the side port of the sheath; results need not be analyzedprior 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 oftheir branches) with:

• Stenosis of ≥70% and <l00%; or

• Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia viapositive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90, orIVUS 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 priorto contrast injection involving both sides of the arterial wall in at least onelocation and total length of calcium of at least 15 mm and extending partiallyinto the target lesion, or

• Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), withpresence 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 indexprocedure;

• New York Heart Association (NYHA) class III or IV heart failure at time of indexprocedure;

• 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, oron 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 anunprotected left main lesion;

• Chronic Total Occlusion;

• Target lesion is located in a native vessel that can only be reached by goingthrough a saphenous vein or arterial bypass graft;