RecruitingNot ApplicableNCT07510438

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

Sponsor

Amplitude Vascular Systems, Inc.

Enrollment

15 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)

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

Min Age: 18 Years

Inclusion Criteria6

≥ 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

Exclusion Criteria11

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPulse Intravascular Lithotripsy (Pulse IVL)

The 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.