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

30. april 2019 oppdatert av: Proteon Therapeutics

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

29

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Long Beach, California, Forente stater, 90822
        • VA Medical Center Long Beach
    • Colorado
      • Denver, Colorado, Forente stater, 80220
        • VA Eastern Colorado Healthcare System
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • UF Health at the University of Florida
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Forente stater, 02135
        • Steward St. Elizabeth's Medical
    • Michigan
      • Wyoming, Michigan, Forente stater, 49519
        • Metro Health Hospital
    • Texas
      • Austin, Texas, Forente stater, 78756
        • Cardiothoracic and Vascular Surgeons
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Health System
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Screening: Initial study inclusion criteria

  1. Age of at least 18 years.
  2. Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
  3. Rutherford category 3-5.
  4. De novo lesion, not previously treated by angioplasty, atherectomy or stenting.
  5. Scheduled to undergo angioplasty of the distal popliteal, tibial or peroneal arteries.
  6. 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.
  7. Ability to understand and comply with the requirements of the entire study and communicate with the study team.

  8. Ability to provide written informed consent using a document that has been approved by the required institutional review board.

    Procedure: Study inclusion criteria to be determined at the time of the angioplasty procedure

  9. Atherosclerotic lesion with >50% stenosis in the popliteal (distal to the center of the knee joint space, the P3 segment), tibial or peroneal artery prior to angioplasty.
  10. Successful revascularization without the use of stenting of the target lesion; no flow limiting dissection and <30% residual lumen stenosis as compared with an adjacent non-diseased lumen diameter.

Exclusion Criteria Screening: Initial study exclusion criteria

  1. 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).
  2. Planned above ankle amputation on ipsilateral limb within 4 weeks of study drug administration.
  3. Prior or planned stenting of the target lesion.
  4. Deep vein thrombosis within the past 3 months.
  5. Known bleeding disorder.
  6. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin G20210A mutation).
  7. Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal.
  8. Renal failure with existing dependence on dialysis or an eGFR by MDRD calculation of < 20 mL/min/1.73 m2.
  9. Pregnancy, lactation or plans to become pregnant during the course of the study.
  10. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
  11. Malignancy or treatment for malignancy within the previous 12 months with the exception of localized basal cell or squamous cell skin cancer, or any cancer in situ.
  12. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

  13. Known allergy to radiocontrast agents.

    Procedure:

    Exclusion criteria to be determined at the time of the angioplasty procedure

  14. Reference vessel diameter < 2 mm and > 8 mm.
  15. Severe concentric medial calcification of the target lesion thought to interfere with study drug delivery to the adventitia based on fluoroscopic appearance.
  16. Aneurysm in the target vessel.
  17. Failure to cross the target lesion with a guide wire; however subintimal wire crossing is allowed.
  18. Stenting of the target lesion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Legemiddel: vonapanitase
Andre navn:
  • PRT-201
Placebo komparator: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
Legemiddel: Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of adverse events
Tidsramme: Up to 6 months following study drug administration
Safety assessments include physical exams and routine serum chemistry and hematology tests
Up to 6 months following study drug administration
Technical success of perivascular injection
Tidsramme: 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
Intraprocedural

Andre resultatmål

Resultatmål
Tidsramme
Minimum lumen diameter [MLD]
Tidsramme: Intraprocedural and 6 months following study drug administration
Intraprocedural and 6 months following study drug administration
Minimum lumen area [MLA]
Tidsramme: Intraprocedural and 6 months following study drug administration
Intraprocedural and 6 months following study drug administration
Incidence of arterial occlusion
Tidsramme: 14 days and 6 months following study drug administration
14 days and 6 months following study drug administration
Rutherford-kategorien
Tidsramme: 14 og 28 dager og 6 måneder etter administrering av studiemedisin
14 og 28 dager og 6 måneder etter administrering av studiemedisin
Ankel-brachial indeks [ABI]
Tidsramme: 14 dager og 6 måneder etter administrering av studiemedisin
14 dager og 6 måneder etter administrering av studiemedisin
Vascular Quality of Life Questionnaire-6 [VascuQol-6
Tidsramme: 14 days and 6 months following study drug administration
14 days and 6 months following study drug administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Proteon Therapeutics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2016

Primær fullføring (Faktiske)

30. april 2019

Studiet fullført (Faktiske)

30. april 2019

Datoer for studieregistrering

Først innsendt

3. november 2016

Først innsendt som oppfylte QC-kriteriene

3. november 2016

Først lagt ut (Anslag)

6. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PRT-201-115

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