Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)

Phase 1

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Placebo; Drug: vonapanitase

• Registration Number: NCT02956993
• Lead Sponsor: Proteon Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Status Verified: 2019-04
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Vonapanitase	vonapanitase	Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.

Primary Outcome Measures

Name	Time	Method
Technical success of perivascular injection	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	Up to 6 months following study drug administration	Safety assessments include physical exams and routine serum chemistry and hematology tests

Trial Locations

Locations (9)

VA Medical Center Long Beach; 🇺🇸 Long Beach, California, United States

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States

Metro Health Hospital; 🇺🇸 Wyoming, Michigan, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Cardiothoracic and Vascular Surgeons; 🇺🇸 Austin, Texas, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Steward St. Elizabeth's Medical; 🇺🇸 Boston, Massachusetts, United States

VA Eastern Colorado Healthcare System; 🇺🇸 Denver, Colorado, United States