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.
≥ 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
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.
Single group
Pulse Intravascular Lithotripsy (Pulse IVL)
DeviceThe Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of severely calcified stenotic de novo coronary arteries prior to stenting in patients with coronary artery disease.
Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events
Target lesion failure (TLF)
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