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Vaso Acelular Humano Humacyte (HAV) em Pacientes com Trauma Vascular

1 de julho de 2026 atualizado por: Humacyte, Inc.

Um estudo de fase 2 para a avaliação da segurança e eficácia do vaso acelular humano de Humacyte para substituição ou reconstrução vascular em pacientes com trauma vascular vascular com risco de vida ou membro

Este estudo avalia o uso do Vaso Acelular Humano (HAV) em adultos com trauma vascular abaixo do pescoço submetidos a cirurgia vascular reconstrutiva. Haverá uma coorte de torso e uma coorte de membros. Todos os indivíduos serão implantados com um HAV como um vaso de interposição ou bypass usando técnicas cirúrgicas vasculares padrão. Não há braço de controle.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Este é um estudo de fase 2 prospectivo, multicêntrico, multicoorte, não randomizado em até 40 pacientes adultos com trauma vascular com risco de vida ou membro que requer reparo cirúrgico. Haverá uma coorte de membros e uma coorte de torso. A coorte de membros incluirá pacientes que necessitam de reparo de um vaso contido na extremidade superior ou inferior. A coorte de torso inclui pacientes que necessitam de reparo de vasos dentro do tórax (excluindo o coração), abdômen e retroperitônio. Os indivíduos serão implantados com um Vaso Acelular Humano Humacyte (HAV) como um vaso de interposição ou desvio usando técnicas cirúrgicas vasculares padrão. Não há braço de controle.

A duração do estudo ativo para cada participante do estudo será de 36 meses a partir da implantação do HAV ou até a falha/remoção/morte do HAV, se anterior. O acompanhamento após o mês 12 envolverá a captura de informações sobre as avaliações realizadas nas visitas clínicas de rotina do "atendimento padrão" ou pelo acompanhamento telefônico com o paciente ou seu médico com exame físico e ultrassom no mês 24 e no mês 36

A duração total esperada do estudo clínico é de 61 meses (24 meses de inscrição e 36 meses de acompanhamento).

Tipo de estudo

Intervencional

Inscrição (Real)

72

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92037
        • Jacob Medical Center at UC San Diego
      • Los Angeles, California, Estados Unidos, 90033
        • Keck Hospital of University of Southern California (USC)
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Cener
      • Orange, California, Estados Unidos, 92868
        • UCI Medical Center
      • Sacramento, California, Estados Unidos, 95817
        • University California, Davis
      • San Diego, California, Estados Unidos, 92103
        • University of California San Diego (UCSD) Medical Center
    • Colorado
      • Denver, Colorado, Estados Unidos, 80204
        • Ernest E Moore Shock Trauma Center at Denver Health
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32209
        • UF Health Jacksonville
      • Miami, Florida, Estados Unidos, 33136
        • Ryder Trauma Center
      • Miami, Florida, Estados Unidos, 33136
        • Jackson South Medical Center
      • Tampa, Florida, Estados Unidos, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Grady Memorial Hospital
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, Estados Unidos, 21201
        • R Adams Cowley Baltimore Shock Trauma
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Saint Louis University (SLU)
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • Cooper University Hospital
      • Newark, New Jersey, Estados Unidos, 07103
        • Rutgers New Jersey Medical School
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Duke University Hospital
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest School of Medicine
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Atrium Health Wake Forest Baptist Medical Center
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Penn Presbyterian Medical Center
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, Estados Unidos, 78701
        • The University of Texas - Dell Medical School
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center - Vascular Surgery Department
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  1. Pacientes com lesão traumática com risco de vida ou de membro em um vaso arterial no membro ou tronco, exceto o coração, que requer substituição ou reconstrução
  2. A imagem pré-operatória ou o exame clínico indicam que o vaso danificado tem um comprimento de defeito ≤ 38 cm e é de tamanho adequado para o vaso acelular humano (HAV) de 6 mm, de acordo com o julgamento do cirurgião, levando em consideração a vasoconstrição e as considerações situacionais de entrada e saída.
  3. O enxerto de veia autóloga não é viável no julgamento do cirurgião (por exemplo, devido à falta de conduto adequado, presença de insuficiência venosa grave) ou não é desejável devido à urgência da revascularização
  4. Dos 18 aos 85 anos, inclusive
  5. Capaz de se comunicar significativamente com a equipe de investigação e capaz de cumprir todos os procedimentos do estudo. Se o paciente estiver inconsciente, as informações de uma testemunha confiável indicam que o paciente normalmente seria capaz de cumprir os procedimentos do estudo
  6. O paciente ou parente é capaz, disposto e competente para dar consentimento informado
  7. Esperança de vida de pelo menos 1 ano

Critério de exclusão:

  1. Pontuação de gravidade de extremidade mutilada (MESS) de ≥ 7
  2. Membro com alto risco de amputação apesar da reconstrução vascular (por exemplo, devido a lesão por esmagamento)
  3. Lesões catastróficas que tornam a sobrevivência improvável (p. Escala Abreviada de Lesões (AIS) > 5 ou Pontuação de Gravidade das Lesões (ISS) > 60)
  4. HAV não pode ser usado para reparo da artéria coronária
  5. mulheres grávidas conhecidas
  6. Condição médica conhecida que impediria a terapia antiplaquetária de longo prazo após a resolução de lesões agudas
  7. Qualquer outra condição que, no julgamento do investigador, impeça a avaliação adequada da segurança e eficácia do HAV
  8. Exposição anterior ao HAV
  9. Participação conhecida em qualquer estudo investigativo nos últimos 30 dias
  10. Funcionários do patrocinador ou pacientes que são funcionários ou parentes do investigador

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Acellular Tissue Engineered Vessel (ATEV)
Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques.
Biológico: Acellular Tissue Engineered Vessel (ATEV)
The investigational medicinal product (IMP) - the Acellular Tissue Engineered Vessel (ATEV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The ATEV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.
Outros nomes:
  • Vaso acelular humano (hav)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Prazo: 30 days from time of implantation
Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
30 days from time of implantation
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Prazo: 30 days from time implantation
Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
30 days from time implantation

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Prazo: 30 days from time of implantation
Rate of secondary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Secondary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).
30 days from time of implantation
HAV Infection Free Rate at Day 30 in the All HAV Group
Prazo: 30 days from time of implantation
The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the specified follow-up milestone, evaluated across the entire overall study population. An infection event is defined by clinical signs coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation.
30 days from time of implantation
Limb Salvage Rate at Day 30 in the All HAV Group
Prazo: 30 Days from time of implantation
Rate of successful limb salvage at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the follow-up window.
30 Days from time of implantation
Survival Rate at Day 30 in the All HAV Group
Prazo: 30 Days from time of implantation
Survival at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.
30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-fee HAV rates through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
Prazo: 12 months from implantation
Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from implantation
Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of infection-free HAV rates through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
Prazo: 36 months from implantation
Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Prazo: 30 days from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Prazo: 12 months from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Prazo: 36 months from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
36 months from time of implantation
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Prazo: 30 days from time of implantation
Rate of secondary patency at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Secondary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).
30 days from time of implantation
HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Prazo: 30 days from time of implantation
The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the follow-up period. An infection event is defined by clinical signs (e.g., localized purulence, exposed graft, erythema) coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation. Participants who did not experience an adjudicated graft infection are considered infection-free.
30 days from time of implantation
Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Prazo: 30 Days from time of implantation
Rate of successful limb salvage at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the 30-day follow-up window.
30 Days from time of implantation
Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Prazo: 30 Days from time of implantation
Survival at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.
30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
Prazo: 12 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
12 months from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
Prazo: 36 months from time of implantation
Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.
36 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Prazo: 30 days from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Prazo: 12 months from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Prazo: 36 months from time of implantation
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
36 months from time of implantation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Humacyte, Inc.

Colaboradores

U.S. Army Medical Research and Development Command
Atlantic Research Group

Investigadores

  • Diretor de estudo: Shamik Parikh, MD, Humacyte, Inc.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2018

Conclusão Primária (Real)

19 de setembro de 2023

Conclusão do estudo (Real)

15 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de dezembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de dezembro de 2016

Primeira postagem (Estimado)

29 de dezembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CLN-PRO-V005

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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