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Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
NCT06457685 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE Pulse Intravascular Lithotripsy (Pulse IVL)
Study Locations (19)
New York
- NYU Langone — New York
- Mount Sinai — New York
- Columbia University and New York Presbyterian Hospital (NYPH) — New York
Ohio
- The Christ Hospital — Cincinnati
- University Hospital- Cleveland Medical Center — Cleveland
- OhioHealth Riverside — Columbus
Pennsylvania
- Mainline Health Lankenau — Bryn Mawr
- UPMC Pinnacle — Mechanicsburg
Texas
- Ascension Seton — Austin
- The Heart Hospital Baylor Plano — Plano
Arkansas
- Arkansas Heart Hospital — Little Rock
California
- Vascular and Interventional Specialists of Orange County — Orange
Colorado
- Advanced Heart and Vein Center — Thornton
Georgia
- Piedmont Heart Institute — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2024-09-05 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06457685
The ClinicalTrials.gov registry entry for NCT06457685 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amplitude Vascular Systems, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peripheral Arterial Disease (PAD) appearing as the primary indexed condition, and to 1 intervention — of which Pulse Intravascular Lithotripsy (Pulse IVL) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06457685 reports 19 study locations spanning 13 distinct geographic areas — top geographies include New York, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06457685 about?
NCT06457685 is a clinical study titled "Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial". 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, superficia...
What is the current status of trial NCT06457685?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 115 participants. The study started on 2024-09-05. Estimated completion is 2026-08.
What conditions does trial NCT06457685 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease (PAD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06457685?
The interventions under investigation include: Pulse Intravascular Lithotripsy (Pulse IVL) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06457685?
This trial is sponsored by Amplitude Vascular Systems, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06457685 being conducted?
This trial has 19 study locations across Arkansas, California, Colorado, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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