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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 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. The trial reports 19 study locations across 13 states.

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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.

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

FieldValue
Enrollment Target 115 participants
Start Date 2024-09-05
Est. Completion 2026-08
Phase NA

Sponsor

Amplitude Vascular Systems

1 total trials

What the Registry Record Tells You About NCT06457685

The ClinicalTrials.gov registry entry for NCT06457685 describes a study currently listed as active not recruiting, categorized as NA. 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.

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 reports 19 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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