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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Pulse Intravascular Lithotripsy (Pulse IVL) for people with coronary arterial disease (cad). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.