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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
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.
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Vascular and Interventional Specialists of Orange County
Orange, California, United States
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.
Time frame: 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: Time Frame: Day of procedure
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.
Time frame: 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.
Time frame: Day of procedure
Clinically Driven Target Lesion Revascularization
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Advanced Heart and Vein Center
Thornton, Colorado, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Mercy Hospital South
St Louis, Missouri, United States
Advanced Endovascular Physicians
West Orange, New Jersey, United States
NYU Langone
New York, New York, United States
Mount Sinai
New York, New York, United States
Columbia University and New York Presbyterian Hospital (NYPH)
New York, New York, United States
...and 9 more locations
Freedom from clinically driven target vessel revascularization as assessed by clinical presentation and diagnostic imaging.
Time frame: 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.
Time frame: 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.
Time frame: Day of procedure
Ankle Brachial Index (ABI)
Change in Ankle Brachial Index (ABI) of the target limb from baseline to follow-up
Time frame: Within 30 days and six months of procedure
Walking Impairment Questionnaire (WIQ)
Change in WIQ from baseline to follow-up
Time frame: Within 30 days and six months of procedure
Freedom from major adverse events
Freedom from major adverse events
Time frame: Six months