Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
NCT Number: NCT06457685
Acronym: POWER PAD 2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Arterial Disease (PAD)
Interventions: DEVICE: Pulse Intravascular Lithotripsy (Pulse IVL)
Sponsor: Amplitude Vascular Systems, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-03

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.

Primary Outcome Measures: Composite of New Onset Major Adverse Events (MAE), 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., Within 30-days of procedure|Procedural Success, 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., Time Frame: Day of procedure
Secondary Outcome Measures: Device Success, 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., Day of procedure|Clinical Success, 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., Day of procedure|Clinically Driven Target Lesion Revascularization, Freedom from clinically driven target vessel revascularization as assessed by clinical presentation and diagnostic imaging., Within 30 days and six months of procedure|Patency, Target vessel patency by Duplex ultrasound, defined as freedom from \> 50% restenosis, as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5., Within 30 days and six months of procedure|Technical Success, 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., Day of procedure|Ankle Brachial Index (ABI), Change in Ankle Brachial Index (ABI) of the target limb from baseline to follow-up, Within 30 days and six months of procedure|Walking Impairment Questionnaire (WIQ), Change in WIQ from baseline to follow-up, Within 30 days and six months of procedure|Freedom from major adverse events, Freedom from major adverse events, Six months
Other Outcome Measures: Prevalence of post-Pulse IVL Adjudicative Therapy, Prevalence of post-Pulse IVL Adjudicative Therapy, Day of procedure