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Procedure

Pulse IVL for Peripheral Arterial Disease (POWER PAD 2 Trial)

N/A
Recruiting
Led By Christopher Metzger, MD
Research Sponsored by Amplitude Vascular Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>18 years old
Rutherford Clinical Category 2, 3, or 4 of the target limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of the Pulse IVL System for treating blockages in leg arteries caused by calcium buildup in patients with peripheral arterial disease."

Who is the study for?
This trial is for adults over 18 with Peripheral Arterial Disease, specifically those with a low ankle-brachial index or significant artery narrowing confirmed by imaging. Participants should be experiencing certain symptoms and must be expected to live at least another year. They need to agree to the study's procedures and sign consent.
What is being tested?
The POWER PAD 2 trial is testing the safety and effectiveness of Pulse Intravascular Lithotripsy (Pulse IVL) in treating calcified blockages in leg arteries. This single-arm study involves patients receiving this treatment without being compared to another group.
What are the potential side effects?
While specific side effects are not listed, treatments like Pulse IVL could potentially cause discomfort, bruising, bleeding or infection at the catheter insertion site, arterial damage, or reactions related to breaking up artery calcifications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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My leg has mild to moderate pain or sores due to poor blood flow.
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My leg blood flow is poor, confirmed by a test or imaging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of New Onset Major Adverse Events (MAE)
Procedural Success
Secondary study objectives
Ankle Brachial Index (ABI)
Clinical Success
Clinically Driven Target Lesion Revascularization
+5 more
Other study objectives
Prevalence of post-Pulse IVL Adjudicative Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulse Intravascular Lithotripsy™ (Pulse IVL™)Experimental Treatment1 Intervention
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Find a Location

Who is running the clinical trial?

Amplitude Vascular Systems, Inc.Lead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
9 Patients Enrolled for Peripheral Arterial Disease
Christopher Metzger, MDPrincipal InvestigatorOhio Health
3 Previous Clinical Trials
21,025 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
13 Patients Enrolled for Peripheral Arterial Disease
~80 spots leftby Sep 2025
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