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

AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study

A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of 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 within 10 mm of the target lesion.