AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease

Key Inclusion Criteria: * ≥ 18 years of age * Subjects with native coronary artery disease * Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months * The target lesion must be a single de novo coronary lesion * The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \<100% or Stenosis ≥50% and \<70% with evidence of ischemia * Lesion length must not exceed 44 mm Key Exclusion Criteria: * Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure. * Subject has New York Heart Association (NYHA) class III or IV heart failure. * Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis. * Subject has a previous stent in the target vessel implanted within last six months. * Unprotected LMCA diameter stenosis \>30%. * Target lesion has a myocardial bridge. * Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees. * Evidence of aneurysm in target vessel within 10 mm of the target lesion. * Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA. * Target lesion is a bifurcation with ostial diameter stenosis ≥30%. * Any previous stent…