- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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California
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Long Beach, California, Förenta staterna, 90822
- VA Medical Center Long Beach
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- VA Eastern Colorado Healthcare System
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Florida
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Gainesville, Florida, Förenta staterna, 32610
- UF Health at the University of Florida
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
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Boston, Massachusetts, Förenta staterna, 02135
- Steward St. Elizabeth's Medical
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Michigan
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Wyoming, Michigan, Förenta staterna, 49519
- Metro Health Hospital
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Texas
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Austin, Texas, Förenta staterna, 78756
- Cardiothoracic and Vascular Surgeons
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Health System
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
|
Andra namn:
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Placebo-jämförare: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of adverse events
Tidsram: 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
Tidsram: 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
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Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Minimum lumen diameter [MLD]
Tidsram: 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]
Tidsram: 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
Tidsram: 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
Tidsram: 14 och 28 dagar och 6 månader efter administrering av studieläkemedlet
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14 och 28 dagar och 6 månader efter administrering av studieläkemedlet
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Ankel-armindex [ABI]
Tidsram: 14 dagar och 6 månader efter administrering av studieläkemedlet
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14 dagar och 6 månader efter administrering av studieläkemedlet
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Vascular Quality of Life Questionnaire-6 [VascuQol-6
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRT-201-115
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