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)

May 14, 2026 updated by: Amplitude Vascular Systems, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Recruiting
        • Monash Health, Victorian Heart Hospital
        • Principal Investigator:
          • Robert Gooley, MD
  • New Zealand
      • Auckland, New Zealand, 1142
        • Recruiting
        • Auckland City Hospital
        • Principal Investigator:
          • Jithendra Somaratne, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulse Intravascular Lithotripsy™ (Pulse IVL™)
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events
Time Frame: Completion of study procedure
Completion of study procedure
Target lesion failure (TLF)
Time Frame: Within 30 days of study procedure
Within 30 days of study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amplitude Vascular Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CL-00014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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