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POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling — POWER-PAD-1  

Peripheral Arterial Disease Clinical Trial

Official title:
A Prospective, Single-Arm, Multicenter, Feasibility Study to Evaluate Safety and Performance of the Amplitude Vascular System (AVS) Pulse Peripheral Intravascular Lithotripsy (IVL) for Treating Subjects With Calcific Femoropopliteal Arteries in Conjunction With Adjunctive Therapy

Clinical Trial Summary

The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.

Clinical Trial Description

Amplitude Vascular System intendeds to conduct a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter in subjects with stenotic lesions of the superficial femoral and/or popliteal arteries (Rutherford Category 2 to 4 of the target limb) with a reference vessel diameter (RVD) of 4mm to 6mm and a total length of <60mm. Up to twenty subjects will be enrolled and treated with the Pulse IVL lithotripsy and followed for 6 months. The Pulse Intravascular Lithotripsy Catheter is intended for the pulsatile lithotripsy-enhanced balloon dilation of lesions, including calcified and fibro-calcific lesions in the peripheral vasculature, such as the superficial femoral and popliteal arteries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05192473
Study type Interventional
Source Amplitude Vascular Systems, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date June 28, 2022
Completion date December 31, 2024
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