A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's ATEV for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 55
- 主要终点
- HAV primary patency
研究概览
简要总结
This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be an extremity cohort and an torso cohort. All subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
详细描述
This is a prospective, multicenter, multi cohort, non-randomized phase 2/3 study in adult patients with life or limb threatening vascular trauma which requires surgical repair.
There will be an extremity cohort and a torso cohort. The extremity cohort will include patients who require repair of a vessel contained to the upper or lower extremity. The torso cohort includes patients who require repair of vessels within the thorax (excluding the heart), abdomen, and retroperitoneum. Subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
The active study duration for each study participant will be 36 months from implantation or until ATEV failure/ removal/ death, if earlier. Follow up after month 12 will involve the capture of information on assessments performed at "standard of care" routine clinic visits or by telephone follow up with the patient or his/her physician with physical exam and ultrasound at month 24 and month 36.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
- •Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
- •Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization
- •Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
- •Patient or relative is able, willing and competent to give informed consent
- •Life expectancy of at least 1 year
排除标准
- •Mangled Extremity Severity Score (MESS) of ≥ 7
- •Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
- •Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) >60)
- •ATEV may not be used for coronary artery repair
- •Known pregnant women
- •Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
- •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the ATEV
- •Previous exposure to ATEV
- •Known participation in any investigational study within the last 30 days
- •Employees of the sponsor or patients who are employees or relatives of the investigator
结局指标
主要结局
HAV primary patency
时间窗: 30 days
Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
Frequency and Severity of Adverse Events
时间窗: 36 months
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
时间窗: 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.
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup
时间窗: 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.
次要结局
- Rate of HAV interventions(36 months)
- HAV secondary patency(36 months)
- Frequency of HAV aneursym formation(36 months)
- Frequency of HAV removal(36 months)
- HAV remodeling as shown by histopathology of any clinical explants(36 months)
- Limb viability (avoidance of amputation; limb cohort only)(36 months)
- HAV primary patency(36 months)
- HAV primary assisted patency(36 months)
- Patient survival(36 months)
- Frequency of anastomotic bleeding or spontaneous rupture(36 months)
- Frequency of HAV infection(36 months)
- Frequency of HAV thrombosis(36 months)
- Frequency of HAV pseudoaneursym formation(36 months)
- Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)(36 months)
- Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group(30 days from time of implantation)
- HAV Infection Free Rate at Day 30 in the All HAV Group(30 days from time of implantation)
- Limb Salvage Rate at Day 30 in the All HAV Group(30 Days from time of implantation)
- Survival Rate at Day 30 in the All HAV Group(30 Days from time of implantation)
- Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group(12 months from time of implantation)
- Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group(12 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group(12 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group(12 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group(12 months from implantation)
- Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group(36 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group(36 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group(36 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group(36 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group(36 months from implantation)
- HAV Interventions Required to Maintain/Restore Patency in the All HAV Group(30 days from time of implantation)
- HAV Interventions Required to Maintain/Restore Patency in the All HAV Group(12 months from time of implantation)
- HAV Interventions Required to Maintain/Restore Patency in the All HAV Group(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(30 days from time of implantation)
- HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup(30 days from time of implantation)
- Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup(30 Days from time of implantation)
- Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup(30 Days from time of implantation)
- Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup(12 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup(12 months from time of implantation)
- Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup(12 months from time of implantation)
- Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup(12 months from time of implantation)
- Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup(12 months from time of implantation)
- Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup(36 months from time of implantation)
- Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup(36 months from time of implantation)
- Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup(36 months from time of implantation)
- Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup(36 months from time of implantation)
- Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup(36 months from time of implantation)
- HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup(30 days from time of implantation)
- HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup(12 months from time of implantation)
- HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup(36 months from time of implantation)