- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02956993
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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Long Beach, California, Forenede Stater, 90822
- VA Medical Center Long Beach
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- VA Eastern Colorado Healthcare System
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- UF Health at the University of Florida
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Boston, Massachusetts, Forenede Stater, 02135
- Steward St. Elizabeth's Medical
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Michigan
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Wyoming, Michigan, Forenede Stater, 49519
- Metro Health Hospital
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Texas
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Austin, Texas, Forenede Stater, 78756
- Cardiothoracic and Vascular Surgeons
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Health System
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Screening: Initial study inclusion criteria
- Age of at least 18 years.
- Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
- Rutherford category 3-5.
- De novo lesion, not previously treated by angioplasty, atherectomy or stenting.
- Scheduled to undergo angioplasty of the distal popliteal, tibial or peroneal arteries.
- 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.
Procedure: Study inclusion criteria to be determined at the time of the angioplasty procedure
- 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.
- 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
- 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).
- Planned above ankle amputation on ipsilateral limb within 4 weeks of study drug administration.
- Prior or planned stenting of the target lesion.
- Deep vein thrombosis within the past 3 months.
- Known bleeding disorder.
- Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin G20210A mutation).
- Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal.
- Renal failure with existing dependence on dialysis or an eGFR by MDRD calculation of < 20 mL/min/1.73 m2.
- Pregnancy, lactation or plans to become pregnant during the course of the study.
- Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
- 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.
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
Known allergy to radiocontrast agents.
Procedure:
Exclusion criteria to be determined at the time of the angioplasty procedure
- Reference vessel diameter < 2 mm and > 8 mm.
- Severe concentric medial calcification of the target lesion thought to interfere with study drug delivery to the adventitia based on fluoroscopic appearance.
- Aneurysm in the target vessel.
- Failure to cross the target lesion with a guide wire; however subintimal wire crossing is allowed.
- Stenting of the target lesion.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
|
Andre navne:
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Placebo komparator: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of adverse events
Tidsramme: Up to 6 months following study drug administration
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Safety assessments include physical exams and routine serum chemistry and hematology tests
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Up to 6 months following study drug administration
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Technical success of perivascular injection
Tidsramme: Intraprocedural
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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
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Intraprocedural
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Minimum lumen diameter [MLD]
Tidsramme: Intraprocedural and 6 months following study drug administration
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Intraprocedural and 6 months following study drug administration
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Minimum lumen area [MLA]
Tidsramme: Intraprocedural and 6 months following study drug administration
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Intraprocedural and 6 months following study drug administration
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Incidence of arterial occlusion
Tidsramme: 14 days and 6 months following study drug administration
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14 days and 6 months following study drug administration
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Rutherford kategori
Tidsramme: 14 og 28 dage og 6 måneder efter administration af studielægemidlet
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14 og 28 dage og 6 måneder efter administration af studielægemidlet
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Ankel-brachial indeks [ABI]
Tidsramme: 14 dage og 6 måneder efter administration af studielægemidlet
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14 dage og 6 måneder efter administration af studielægemidlet
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Vascular Quality of Life Questionnaire-6 [VascuQol-6
Tidsramme: 14 days and 6 months following study drug administration
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14 days and 6 months following study drug administration
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRT-201-115
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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