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NCT06457685 · ClinicalTrials.gov registry record · NA
Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
A NA study of Peripheral Arterial Disease (PAD), sponsored by Amplitude Vascular Systems.
- Active
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 19
- Study locations
NCT06457685: Active NA study of Peripheral Arterial Disease (PAD), sponsored by Amplitude Vascular Systems.
NCT06457685 is a NA study of Peripheral Arterial Disease (PAD) that is active but no longer recruiting, run by Amplitude Vascular Systems. The registered enrollment target is 115 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06457685, a NA study of Peripheral Arterial Disease (PAD), is active but no longer recruiting, sponsored by Amplitude Vascular Systems.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
MAE defined as experiencing any of the following: • The need for emergency surgical revascularization of target limb * Unplanned target limb amputation (above the ankle) * Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pha
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 |
What the registry record for NCT06457685 still lists
NCT06457685 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
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.
NCT06457685 lists 19 locations in 13 states (New York, Ohio, Pennsylvania).
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).
What interventions are being tested in trial NCT06457685?
The interventions under investigation include: Pulse Intravascular Lithotripsy (Pulse IVL) (DEVICE).
Who is sponsoring clinical trial NCT06457685?
This trial is sponsored by Amplitude Vascular Systems, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Peripheral Arterial Disease (PAD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06457685's enrollment target sits among peer trials
115 810th of 2000 higher than 1,190 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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