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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
VA Medical Center Long Beach
Long Beach, California, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, United States
UF Health at the University of Florida
Gainesville, Florida, United States
Incidence of adverse events
Safety assessments include physical exams and routine serum chemistry and hematology tests
Time frame: Up to 6 months following study drug administration
Technical success of perivascular 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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Boston Medical Center
Boston, Massachusetts, United States
Steward St. Elizabeth's Medical
Boston, Massachusetts, United States
Metro Health Hospital
Wyoming, Michigan, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States