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

Amplitude Vascular Systems

Status: Not yet enrolling

Conditions: Coronary Arterial Disease (CAD)

Treatments: Device: Pulse Intravascular Lithotripsy (Pulse IVL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07510438

CL-00014

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pulse Intravascular Lithotripsy™ (Pulse IVL™)

Experimental group

Description:

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Treatment:

Device: Pulse Intravascular Lithotripsy (Pulse IVL)