NCT05192473

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Amplitude Vascular Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Pulse Intravascular Lithotripsy System	Treatment with Pulse Intravascular Lithotripsy System

Timeline

• Start date: 2022-06-28
• Primary completion: 2024-06-28
• Completion: 2024-12-31
• First posted: 2022-01-14
• Last updated: 2023-08-04

Locations

3 sites across 3 countries: Australia, Dominican Republic, New Zealand