- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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California
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Long Beach, California, Stati Uniti, 90822
- VA Medical Center Long Beach
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- VA Eastern Colorado Healthcare System
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Florida
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Gainesville, Florida, Stati Uniti, 32610
- UF Health at the University of Florida
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston Medical Center
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Boston, Massachusetts, Stati Uniti, 02135
- Steward St. Elizabeth's Medical
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Michigan
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Wyoming, Michigan, Stati Uniti, 49519
- Metro Health Hospital
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Texas
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Austin, Texas, Stati Uniti, 78756
- Cardiothoracic and Vascular Surgeons
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia Health System
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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Altri nomi:
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Comparatore placebo: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Incidence of adverse events
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
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Minimum lumen diameter [MLD]
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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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Categoria Rutherford
Lasso di tempo: 14 e 28 giorni e 6 mesi dopo la somministrazione del farmaco in studio
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14 e 28 giorni e 6 mesi dopo la somministrazione del farmaco in studio
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Indice caviglia-braccio [ABI]
Lasso di tempo: 14 giorni e 6 mesi dopo la somministrazione del farmaco in studio
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14 giorni e 6 mesi dopo la somministrazione del farmaco in studio
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Vascular Quality of Life Questionnaire-6 [VascuQol-6
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PRT-201-115
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .