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
Cagent Vascular LLC
Lead sponsor
Clinical Accelerator
Collaborator
Australian Healthcare Solutions
Collaborator
Yale Cardiovascular Research Group
Collaborator