The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
Name: vonapanitaseDescription: Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.Type: Drug
Description: Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology testsMeasure: Incidence of adverse events Time: Up to 6 months following study drug administration
Description: Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scaleMeasure: Technical success of percutaneous injection Time: Intraprocedural
Single Group Assignment
There is one SNP
7. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation). --- G20210A ---