Humacyte 人类脱细胞血管 (HAV) 在血管外伤患者中的应用
2026年7月1日 更新者：Humacyte, Inc.
评估 Humacyte 人类脱细胞血管在危及生命或肢体的血管创伤患者中进行血管置换或重建的安全性和有效性的 2 期研究
本研究评估了人类脱细胞血管 (HAV) 在接受血管重建手术的颈部以下血管创伤成人中的应用。
将有一个躯干队列和一个肢体队列。
所有受试者都将使用标准血管外科技术植入 HAV 作为介入血管或旁路。
没有控制臂。
研究概览
地位
地位
完全的
干预/治疗
干预/治疗
详细说明
这是一项前瞻性、多中心、多队列、非随机的 2 期研究，涉及多达 40 名患有危及生命或肢体血管创伤且需要手术修复的成年患者。 将有一个肢体队列和一个躯干队列。 肢体队列将包括需要修复上肢或下肢血管的患者。 躯干队列包括需要修复胸腔（不包括心脏）、腹部和腹膜后血管的患者。 将使用标准血管外科技术将 Humacyte 人类脱细胞血管 (HAV) 作为介入血管或旁路植入受试者。 没有控制臂。
每个研究参与者的积极研究持续时间为从 HAV 植入起 36 个月或直到 HAV 失败/移除/死亡（如果更早）。 第 12 个月后的跟进将涉及收集有关在“护理标准”常规门诊就诊或通过电话跟进患者或其医生在第 24 个月和第 36 个月进行身体检查和超声检查时进行的评估的信息
临床研究的总预期持续时间为 61 个月（入组 24 个月，随访 36 个月）。
研究类型
研究类型
介入性
注册 (实际的)
注册
72
阶段
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
学习联系方式
- 姓名：Elizabeth Taylor
- 电话号码：185 919-313-9633
- 邮箱：etaylor@humacyte.com
研究联系人备份
- 姓名：Mark Tulchinskiy, MD
- 电话号码：919-313-9633
- 邮箱：mtulchinskiy@humacyte.com
学习地点
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Beersheba、以色列、8410101
- Soroka Medical Center - Vascular Surgery Department
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Jerusalem、以色列、9103102
- Shaare Zedek Medical Center
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California
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La Jolla、California、美国、92037
- Jacob Medical Center at UC San Diego
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Los Angeles、California、美国、90033
- Keck Hospital of University of Southern California (USC)
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Cener
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Orange、California、美国、92868
- UCI Medical Center
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Sacramento、California、美国、95817
- University California, Davis
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San Diego、California、美国、92103
- University of California San Diego (UCSD) Medical Center
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Colorado
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Denver、Colorado、美国、80204
- Ernest E Moore Shock Trauma Center at Denver Health
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Florida
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Jacksonville、Florida、美国、32209
- UF Health Jacksonville
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Miami、Florida、美国、33136
- Ryder Trauma Center
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Miami、Florida、美国、33136
- Jackson South Medical Center
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Tampa、Florida、美国、33606
- Tampa General Hospital
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Georgia
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Atlanta、Georgia、美国、30303
- Grady Memorial Hospital
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
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Baltimore、Maryland、美国、21224
- Johns Hopkins Bayview Medical Center
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Baltimore、Maryland、美国、21201
- R Adams Cowley Baltimore Shock Trauma
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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Missouri
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St Louis、Missouri、美国、63110
- Saint Louis University (SLU)
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New Jersey
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Camden、New Jersey、美国、08103
- Cooper University Hospital
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Newark、New Jersey、美国、07103
- Rutgers New Jersey Medical School
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North Carolina
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Durham、North Carolina、美国、27705
- Duke University Hospital
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Winston-Salem、North Carolina、美国、27157
- Wake Forest School of Medicine
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Winston-Salem、North Carolina、美国、27157
- Atrium Health Wake Forest Baptist Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19140
- Temple University Hospital
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Philadelphia、Pennsylvania、美国、19104
- Penn Presbyterian Medical Center
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center
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Texas
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Austin、Texas、美国、78701
- The University of Texas - Dell Medical School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 患有危及生命或肢体外伤的患者，其肢体或躯干动脉血管（心脏除外）需要更换或重建
- 术前影像学或临床检查表明受损血管的缺陷长度≤ 38 厘米，并且根据治疗外科医生的判断，其尺寸与 6 毫米人类脱细胞血管 (HAV) 适当匹配，并考虑了血管收缩和流入和流出的情况。
- 根据治疗外科医生的判断，自体静脉移植是不可行的（例如，因为缺乏合适的导管，存在严重的静脉功能不全），或者因为血运重建的紧迫性而不可取
- 18岁至85岁，包括在内
- 能够与调查人员进行有意义的沟通，并能够遵守整个研究程序。 如果患者失去知觉，则来自可靠证人的信息表明患者通常能够遵守研究程序
- 患者或亲属能够、愿意并有能力给予知情同意
- 至少1年的预期寿命
排除标准：
- 肢体损伤严重程度评分 (MESS) ≥ 7
- 尽管进行了血管重建，但肢体仍有很高的截肢风险（例如，由于挤压伤）
- 使生存不太可能的灾难性伤害（例如 简略伤害量表 (AIS) > 5 或伤害严重程度评分 (ISS) >60）
- HAV 不能用于冠状动脉修复
- 已知孕妇
- 已知的身体状况会在急性损伤消退后排除长期抗血小板治疗
- 研究者判断会妨碍对 HAV 的安全性和有效性进行充分评估的任何其他情况
- 以前接触过 HAV
- 在过去 30 天内已知参与过任何调查研究
- 作为研究者雇员或亲属的申办者雇员或患者
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
手臂数量
1
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
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实验性的：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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
大体时间：30 days from time of implantation
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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.
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30 days from time of implantation
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Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup
大体时间：30 days from time implantation
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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.
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30 days from time implantation
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次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
大体时间：30 days from time of implantation
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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).
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30 days from time of implantation
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HAV Infection Free Rate at Day 30 in the All HAV Group
大体时间：30 days from time of implantation
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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.
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30 days from time of implantation
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Limb Salvage Rate at Day 30 in the All HAV Group
大体时间：30 Days from time of implantation
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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.
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30 Days from time of implantation
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Survival Rate at Day 30 in the All HAV Group
大体时间：30 Days from time of implantation
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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.
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30 Days from time of implantation
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Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group
大体时间：12 months from time of implantation
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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.
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12 months from time of implantation
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Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group
大体时间：12 months from time of implantation
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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.
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12 months from time of implantation
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Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
大体时间：12 months from time of implantation
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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.
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12 months from time of implantation
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Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
大体时间：12 months from time of implantation
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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.
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12 months from time of implantation
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Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
大体时间：12 months from implantation
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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.
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12 months from implantation
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Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group
大体时间：36 months from time of implantation
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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.
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36 months from time of implantation
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Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group
大体时间：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.
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36 months from time of implantation
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Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
大体时间：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.
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36 months from time of implantation
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Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
大体时间：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
|
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Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
大体时间：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.
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36 months from implantation
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HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
大体时间：30 days from time of implantation
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Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
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30 days from time of implantation
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HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
大体时间：12 months from time of implantation
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Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
|
12 months from time of implantation
|
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HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
大体时间：36 months from time of implantation
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Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
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36 months from time of implantation
|
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Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
大体时间：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.
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30 days from time of implantation
|
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Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
|
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Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
大体时间：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
大体时间：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
|
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Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
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Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
|
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Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
大体时间：36 months from time of implantation
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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.
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36 months from time of implantation
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Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
大体时间：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
大体时间：30 days from time of implantation
|
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
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30 days from time of implantation
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HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
合作者
调查人员
调查人员
- 研究主任：Shamik Parikh, MD、Humacyte, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lum Y, Moore EE, Kundi R, Morrison J, Shores JT, Niklason LE, Parikh S. Bioengineered human blood vessels to treat hospital-acquired vascular complications. J Vasc Surg Cases Innov Tech. 2025 Sep 8;11(6):101976. doi: 10.1016/j.jvscit.2025.101976. eCollection 2025 Dec.
- Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-189. doi: 10.1001/jamasurg.2024.4893.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
学习开始
2018年9月1日
初级完成 (实际的)
初级完成
2023年9月19日
研究完成 (实际的)
研究完成
2026年5月15日
研究注册日期
首次提交
首次提交
2016年12月21日
首先提交符合 QC 标准的
首先提交符合 QC 标准的
2016年12月23日
首次发布 (估计的)
首次发布
2016年12月29日
研究记录更新
最后更新发布 (实际的)
最后更新发布
2026年7月29日
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
2026年7月1日
最后验证
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.