WithdrawnPhase 1

Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries

Stopped: Change in operating plans

United States0

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 2-4.
✓. Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR \>2.4.
✓. 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.

Exclusion criteria

✕. Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g., Buerger's disease, vasculitis).
✕. Total occlusion of the SFA or PA in the index leg.
✕. Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
✕. Deep vein thrombosis within the past 3 months.
✕. Known bleeding disorder.
✕. Presence of any arterial aneurysm in the index leg.
✕. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation).
✕. Platelet count \<130K, hematocrit \<30%, bilirubin or ALT \>3.0 times the upper limit of normal.

What they're measuring

Incidence of adverse events

Timeframe: Up to 6 months following study drug administration

Technical success of percutaneous injection

Timeframe: Intraprocedural

Trial details

NCT IDNCT02953496

SponsorProteon Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More Peripheral Artery Disease trials