NCT06457685

Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Amplitude Vascular Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System (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. This study will enroll subjects \>18 years old that are presenting for a peripheral arterial disease intervention for the treatment of peripheral artery disease. Specifically, the subject has moderate to heavily calcified superficial femoral and popliteal arteries, presenting with Rutherford Category 2 to 4 of the target limb, with a reference vessel diameter (RVD) of 4mm to 6.5mm and a total lesion length of ≤ 150mm. Up to 120 subjects will be treated in the study at up to 20 U.S. investigational sites. Subjects will be evaluated at discharge, 30 days and 6 months after procedure.

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DEVICE	Pulse Intravascular Lithotripsy (Pulse IVL)	The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Timeline

• Start date: 2024-09-05
• Primary completion: 2026-03-01
• Completion: 2026-08-01
• First posted: 2024-06-13
• Last updated: 2026-02-18

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study