Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
- Conditions
- Peripheral Arterial Disease (PAD)
- Interventions
- Device: Pulse Intravascular Lithotripsy (Pulse IVL)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pulse Intravascular Lithotripsy™ (Pulse IVL™) Pulse Intravascular Lithotripsy (Pulse IVL) Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
- 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 (14)
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
NYU Langone
🇺🇸New York, New York, United States
Mainline Health Lankenau
🇺🇸Bryn Mawr, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Vascular and Interventional Specialists of Orange County
🇺🇸Orange, California, United States
Advanced Heart and Vein Center
🇺🇸Thornton, Colorado, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Columbia University and New York Presbyterian Hospital (NYPH)
🇺🇸New York, New York, United States
OhioHealth Riverside
🇺🇸Columbus, Ohio, United States
UPMC Pinnacle
🇺🇸Mechanicsburg, Pennsylvania, United States
The Miriam Hospital - Brown University Health Partner
🇺🇸Providence, Rhode Island, United States
Ascension Seton
🇺🇸Austin, Texas, United States