The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.
Primary Safety: Major Adverse Events
Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of: * All cardiovascular death * Major amputation * Clinically-driven target lesion revascularization (CD-TLR)
Time frame: 30 Days
Primary Effectiveness: Procedural Success
Procedural Success, defined as: \<50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment
Time frame: Procedure
Freedom from Major Adverse Events at 6 months
Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization
Time frame: 6 months
Freedom from Major Adverse Events at 12 months
Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization.
Time frame: 12 months
Procedural success of ≤30% residual stenosis of the target lesion
Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment
Time frame: Procedure
Patency rates of target lesion by duplex ultrasound
Patency rates at 30 days, 6 months, and 12 months of target lesion by duplex ultrasound. 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: 30 Days, 6 Months, and 12 Months
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Freedom from clinically-driven target lesion revascularization
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months
Time frame: 30 Days, 6 Months, and 12 Months
Change in Ankle-Brachial Index/Toe-Brachial Index
Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline
Time frame: 30 Days, 6 Months, and 12 Months
Change in Rutherford Category
Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline
Time frame: 30 Days, 6 Months, and 12 Months
Change in Walking Impairment Questionnaire score
Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline
Time frame: 30 Days, 6 Months, and 12 Months
Change in EuroQol-5D-3L
Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline
Time frame: 30 Days, 6 Months, and 12 Months