A Phase 1 Multi-Center, Dose-Escalation Study of Vonapanitase Administered Percutaneously to the Superficial Femoral or Popliteal Artery in Patients With Peripheral Artery Disease

Proteon Therapeutics1 site in 1 countryNovember 2, 2016

ConditionsPeripheral Artery Disease

Interventionsvonapanitase

Drugsvonapanitase

Overview

Phase: Phase 1
Intervention: vonapanitase
Conditions: Peripheral Artery Disease
Sponsor: Proteon Therapeutics
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2, 2016

End Date

April 30, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Proteon Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of at least 18 years.
•Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
•ABI \<0.90 at rest or with exercise, or a toe-brachial index (TBI) \<0.70 if ABI value is \>1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
•Rutherford category 2-
•Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR \>2.
•De novo lesion, not previously treated by angioplasty, atherectomy, or stent.
•If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. Acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner.
•Ability to understand and comply with the requirements of the entire study and communicate with the study team.
•Ability to provide written informed consent using a document that has been approved by the required institutional review board.
•Exclusion Criteria

Exclusion Criteria

Not provided

Arms & Interventions

vonapanitase

Intervention: vonapanitase

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: Up to 6 months following study drug administration

Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology tests

Technical success of percutaneous 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