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Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

NCT06457685 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-02-18

No results posted yet for this study

Summary

POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Conditions

  • Peripheral Arterial Disease (PAD)

Interventions

DEVICE

Pulse Intravascular Lithotripsy (Pulse IVL)

The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Sponsors & Collaborators

  • Amplitude Vascular Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Metzger, MD · Ohio Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2026-03-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

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 NCT06457685 on ClinicalTrials.gov