Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease (PAD)

• Registration Number: NCT06457685
• Lead Sponsor: Amplitude Vascular Systems, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Study Start: 2024-09-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-09
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite of New Onset Major Adverse Events (MAE)	Within 30-days of procedure	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 pharmacologic means to improve flow and results in extended hospitalization.; * Perforations or dissections of grade D or greater that require an intervention such as bailout stenting.
Procedural Success	Time Frame: Day of procedure	Defined as: The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (after adjunctive therapy, if used) as assessed by quantitative angiography via core lab evaluation.

Secondary Outcome Measures

Name	Time	Method
Walking Impairment Questionnaire (WIQ)	Within 30 days and six months of procedure	Change in WIQ from baseline to follow-up
Clinical Success	Day of procedure	The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (after adjunctive therapy, if used) as assessed by quantitative angiography via core lab evaluation and freedom from major adverse events that occur during the procedure.
Clinically Driven Target Lesion Revascularization	Within 30 days and six months of procedure	Freedom from clinically driven target vessel revascularization as assessed by clinical presentation and diagnostic imaging.
Freedom from major adverse events	Six months	Freedom from major adverse events
Patency	Within 30 days and six months of procedure	Target vessel patency by Duplex ultrasound, defined as freedom from \> 50% restenosis, as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5.
Device Success	Day of procedure	The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (prior to adjunctive therapy) as assessed by quantitative angiography via core lab evaluation.
Ankle Brachial Index (ABI)	Within 30 days and six months of procedure	Change in Ankle Brachial Index (ABI) of the target limb from baseline to follow-up
Technical Success	Day of procedure	The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to deliver the Pulse IVL treatment to the desired location in the target vessel.

Trial Locations

Locations (20)

Mercy Hospital South; 🇺🇸 Saint Louis, Missouri, United States

Advanced Endovascular Physicians; 🇺🇸 West Orange, New Jersey, United States

Mount Sinai; 🇺🇸 New York, New York, United States

NC Heart and Vascular Research; 🇺🇸 Raleigh, North Carolina, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

University Hospital- Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Vascular and Interventional Specialists of Orange County; 🇺🇸 Orange, California, United States

Advanced Heart and Vein Center; 🇺🇸 Thornton, Colorado, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

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