A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease
Overview
- Phase
- Phase 1
- Intervention
- vonapanitase
- Conditions
- Peripheral Artery Disease
- Sponsor
- Proteon Therapeutics
- Enrollment
- 29
- Locations
- 9
- Primary Endpoint
- Technical success of perivascular injection
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Intervention: vonapanitase
Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Intervention: Placebo
Outcomes
Primary Outcomes
Technical success of perivascular injection
Time Frame: Intraprocedural
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
Incidence of adverse events
Time Frame: Up to 6 months following study drug administration
Safety assessments include physical exams and routine serum chemistry and hematology tests