The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately following successful angioplasty.
Name: vonapanitaseType: Drug
Name: PlaceboType: Drug
Description: Safety assessments include physical exams 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 perivascular injection Time: Intraprocedural
There is one SNP
6. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin G20210A mutation). --- G20210A ---