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.
Subject is ≥ 18 years of age
Target limb is Rutherford Clinical Category 2, 3 or 4
Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb
Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
Rutherford Clinical Categories 0, 1, 5 and 6
Subject with known pregnancy or is nursing
Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis
Target lesions >150mm by visual estimation
Parallel
Serranator Sonic Intravascular Lithotripsy (IVL) System
DeviceSerration 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)
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
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
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.
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
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
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Cagent Vascular LLC
Lead sponsor
Clinical Accelerator
Collaborator
Australian Healthcare Solutions
Collaborator
Yale Cardiovascular Research Group
Collaborator
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