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

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 within 10 mm of the target lesion.