- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Long Beach, California, Estados Unidos, 90822
- VA Medical Center Long Beach
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- VA Eastern Colorado Healthcare System
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- UF Health at the University of Florida
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Boston, Massachusetts, Estados Unidos, 02135
- Steward St. Elizabeth's Medical
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Michigan
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Wyoming, Michigan, Estados Unidos, 49519
- Metro Health Hospital
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Texas
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Austin, Texas, Estados Unidos, 78756
- Cardiothoracic and Vascular Surgeons
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia Health System
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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Outros nomes:
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Comparador de Placebo: Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of adverse events
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Prazo |
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Minimum lumen diameter [MLD]
Prazo: 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]
Prazo: 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
Prazo: 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
Prazo: 14 e 28 dias e 6 meses após a administração do medicamento do estudo
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14 e 28 dias e 6 meses após a administração do medicamento do estudo
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Índice tornozelo-braquial [ITB]
Prazo: 14 dias e 6 meses após a administração do medicamento do estudo
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14 dias e 6 meses após a administração do medicamento do estudo
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Vascular Quality of Life Questionnaire-6 [VascuQol-6
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRT-201-115
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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