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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.
University of Virginia Health System
Charlottesville, Virginia, United States
Incidence of adverse events
Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology tests
Time frame: Up to 6 months following study drug administration
Technical success of percutaneous injection
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 scale
Time frame: Intraprocedural
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