Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Vaso acelular humano Humacyte (HAV) en pacientes con traumatismo vascular

1 de julio de 2026 actualizado por: Humacyte, Inc.

Un estudio de fase 2 para la evaluación de la seguridad y la eficacia del vaso acelular humano de Humacyte para el reemplazo o la reconstrucción vascular en pacientes con traumatismos vasculares que amenazan la vida o las extremidades

Este estudio evalúa el uso del Vaso Acelular Humano (VHA) en adultos con traumatismo vascular debajo del cuello que se someten a cirugía reconstructiva vascular. Habrá una cohorte de torso y una cohorte de extremidades. A todos los sujetos se les implantará un HAV como vaso de interposición o derivación utilizando técnicas quirúrgicas vasculares estándar. No hay brazo de control.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Este es un estudio de fase 2 prospectivo, multicéntrico, de múltiples cohortes, no aleatorizado en hasta 40 pacientes adultos con traumatismo vascular que pone en peligro la vida o las extremidades y que requiere reparación quirúrgica. Habrá una cohorte de extremidades y una cohorte de torso. La cohorte de extremidades incluirá pacientes que requieran reparación de un vaso contenido en la extremidad superior o inferior. La cohorte de torso incluye pacientes que requieren reparación de vasos dentro del tórax (excluyendo el corazón), abdomen y retroperitoneo. A los sujetos se les implantará un vaso acelular humano Humacyte (HAV) como vaso de interposición o derivación mediante técnicas quirúrgicas vasculares estándar. No hay brazo de control.

La duración activa del estudio para cada participante del estudio será de 36 meses a partir de la implantación del VHA o hasta el fracaso/eliminación/muerte del VHA si es anterior. El seguimiento después del mes 12 implicará la captura de información sobre las evaluaciones realizadas en las visitas clínicas de rutina "estándar de atención" o por teléfono de seguimiento con el paciente o su médico con examen físico y ultrasonido en el mes 24 y el mes 36

La duración total esperada del estudio clínico es de 61 meses (24 meses de inscripción y 36 meses de seguimiento).

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  1. Pacientes con lesiones traumáticas que amenazan la vida o la extremidad en un vaso arterial en la extremidad o el torso, que no sea el corazón, que requiera reemplazo o reconstrucción
  2. Las imágenes preoperatorias o el examen clínico indican que el vaso dañado tiene una longitud del defecto de ≤ 38 cm y tiene un tamaño apropiado para el vaso acelular humano (HAV) de 6 mm según el criterio del cirujano tratante, teniendo en cuenta la vasoconstricción y las consideraciones situacionales de entrada y salida.
  3. El injerto de vena autóloga no es factible a juicio del cirujano tratante (p. ej., debido a la falta de disponibilidad de un conducto adecuado, presencia de insuficiencia venosa grave) o no es deseable debido a la urgencia de la revascularización.
  4. De 18 a 85 años, ambos inclusive
  5. Capaz de comunicarse de manera significativa con el personal de investigación y capaz de cumplir con todos los procedimientos del estudio. Si el paciente está inconsciente, la información de un testigo confiable indica que el paciente normalmente podría cumplir con los procedimientos del estudio.
  6. El paciente o familiar es capaz, dispuesto y competente para dar su consentimiento informado
  7. Esperanza de vida de al menos 1 año

Criterio de exclusión:

  1. Puntaje de gravedad de extremidad mutilada (MESS) de ≥ 7
  2. Extremidad con alto riesgo de amputación a pesar de la reconstrucción vascular (p. ej., debido a una lesión por aplastamiento)
  3. Lesiones catastróficas que hacen improbable la supervivencia (p. Escala abreviada de lesiones (AIS) > 5 o puntuación de gravedad de la lesión (ISS) > 60)
  4. HAV no se puede utilizar para la reparación de la arteria coronaria
  5. mujeres embarazadas conocidas
  6. Condición médica conocida que impediría la terapia antiplaquetaria a largo plazo después de la resolución de lesiones agudas
  7. Cualquier otra condición que, a juicio del investigador, impida una evaluación adecuada de la seguridad y eficacia del HAV
  8. Exposición previa a VHA
  9. Participación conocida en cualquier estudio de investigación en los últimos 30 días
  10. Empleados del patrocinador o pacientes que son empleados o familiares del investigador

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otros nombres:
  • Vaso acelular humano (HAV)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Humacyte, Inc.

Colaboradores

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

Investigadores

  • Director de estudio: Shamik Parikh, MD, Humacyte, Inc.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2018

Finalización primaria (Actual)

19 de septiembre de 2023

Finalización del estudio (Actual)

15 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de diciembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

23 de diciembre de 2016

Publicado por primera vez (Estimado)

29 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CLN-PRO-V005

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir