The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
Amplitude Vascular System intendeds to conduct a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter in subjects with stenotic lesions of the superficial femoral and/or popliteal arteries (Rutherford Category 2 to 4 of the target limb) with a reference vessel diameter (RVD) of 4mm to 6mm and a total length of \<60mm. Up to twenty subjects will be enrolled and treated with the Pulse IVL lithotripsy and followed for 6 months. The Pulse Intravascular Lithotripsy Catheter is intended for the pulsatile lithotripsy-enhanced balloon dilation of lesions, including calcified and fibro-calcific lesions in the peripheral vasculature, such as the superficial femoral and popliteal arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Treatment with Pulse Intravascular Lithotripsy System
Royal Perth Hospital
Perth, Western Australia, Australia
Centro Medico Moderno
Santo Domingo, Dominican Republic
Auckland City Hospital
Auckland, New Zealand
Device Success
Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without bust below rated burst pressure
Time frame: up to 24 hours
Technical Success
Defined as successful vascular access, completion of endovascular procedure with or without adjunctive therapy, and immediate achievement of less than or equal to 50% residual stenosis of the treated lesion on completion of angiography.
Time frame: up to 24 hours
Procedural Success
Defined as Device Success or Technical Success and absence of procedural complications
Time frame: up to 24 hours
Major Adverse Events
A composite of either unplanned major amputation (above the ankle) or major reintervention of target limb defined as new unplanned surgical bypass graft, the use of thrombectomy or thrombolysis, major surgical graft revision such as a jump graft or an interposition graft, or bail-out stenting at 30 days.
Time frame: 30 days
Freedom from target limb revascularization
Freedom from clinically driven target lesion revascularization at 30-days and 6-months
Time frame: 30 days and 6 months
Clinical Success
Achievement of residual stenosis of the treated lesion on completion of angiography with or without adjunctive therapy
Time frame: up to 24 hours
Rutherford Clinical Category
Improvement in Rutherford Class score at 6 months
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Time frame: 6 months
Ankle-Brachial Index
Change in Ankle Brachial Index (ABI) of the target limb at 30 days
Time frame: 30 days
Quality of Life at 30 days and 6 months
Assessed by EUROQOL - EQ-5D-5L descriptive system (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) questionnaire at 30 days and 6 months reported as a change from baseline. LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems
Time frame: 30 days and 6 months
Walking Capacity
Assessed by the Walking Impairment Questionnaire (WIQ) at 30 days and 6 months reported as a change from baseline.
Time frame: 30 days and 6 months
VacuQol
Change in VascuQol score from pre-procedure to 30-days and 6-months
Time frame: 30 days and 6 months
Major Adverse Event
Major Adverse Limb event or procedure-related death at 30-days
Time frame: 30 days
Major Unplanned Amputation
Major Unplanned Amputation of the target limb at 6 months.
Time frame: 6 months