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POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling

NCT05192473 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-08-04

No results posted yet for this study

Summary

The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Pulse Intravascular Lithotripsy System

Treatment with Pulse Intravascular Lithotripsy System

Sponsors & Collaborators

  • Amplitude Vascular Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Holden, MD · Auckland City Hospital

  • Nelson Encanacion, MD · Centro Medico Moderno

  • Bibombe P Mwipatayi, MD · Royal Perth Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-06-28
Completion
2024-12-31

Countries

  • Australia
  • Dominican Republic
  • 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 NCT05192473 on ClinicalTrials.gov