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

Summary

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.

Eligibility

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.

Conditions2

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