Overview
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.
