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

NCT07510438 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Coronary Arterial Disease (CAD)

Interventions

DEVICE

Pulse 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.

Sponsors & Collaborators

  • Amplitude Vascular Systems, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510438 on ClinicalTrials.gov