혈관 외상 환자의 휴머사이트 인간 무세포 혈관(HAV)
2026년 7월 1일 업데이트: Humacyte, Inc.
생명 또는 사지를 위협하는 혈관 외상 환자의 혈관 대체 또는 재건을 위한 Humacyte의 인간 무세포혈관의 안전성 및 유효성 평가를 위한 2상 연구
이 연구는 혈관 재건 수술을 받는 목 아래 혈관 외상이 있는 성인의 인간 무세포 혈관(HAV) 사용을 평가합니다.
몸통 코호트와 사지 코호트가 있을 것입니다.
모든 피험자는 표준 혈관 수술 기술을 사용하여 중간 혈관 또는 우회로로 HAV를 이식받게 됩니다.
컨트롤 암이 없습니다.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
이것은 외과적 치료가 필요한 생명 또는 사지를 위협하는 혈관 외상이 있는 최대 40명의 성인 환자를 대상으로 한 전향적, 다기관, 다중 코호트, 비무작위 2상 연구입니다. 사지 코호트와 몸통 코호트가 있을 것입니다. 사지 코호트에는 상지 또는 하지에 포함된 혈관의 수리가 필요한 환자가 포함됩니다. 몸통 코호트에는 흉부(심장 제외), 복부 및 후복막 내의 혈관 수리가 필요한 환자가 포함됩니다. 피험자는 표준 혈관 수술 기술을 사용하여 중재 혈관 또는 우회로로서 Humacyte Human Acellular Vessel(HAV)을 이식받게 됩니다. 컨트롤 암이 없습니다.
각 연구 참여자에 대한 활성 연구 기간은 HAV 이식으로부터 36개월 또는 HAV 실패/제거/사망(더 이른 경우)까지입니다. 12개월 후 후속 조치에는 "표준 관리" 일상적인 클리닉 방문 또는 24개월 및 36개월에 신체 검사 및 초음파로 환자 또는 환자의 의사와의 전화 후속 조치에서 수행된 평가에 대한 정보 캡처가 포함됩니다.
임상 연구의 총 예상 기간은 61개월(등록 24개월 및 후속 조치 36개월)입니다.
연구 유형
연구 유형
중재적
등록 (실제)
등록
72
단계
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Elizabeth Taylor
- 전화번호: 185 919-313-9633
- 이메일: etaylor@humacyte.com
연구 연락처 백업
- 이름: Mark Tulchinskiy, MD
- 전화번호: 919-313-9633
- 이메일: mtulchinskiy@humacyte.com
연구 장소
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California
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La Jolla, California, 미국, 92037
- Jacob Medical Center at UC San Diego
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Los Angeles, California, 미국, 90033
- Keck Hospital of University of Southern California (USC)
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Cener
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Orange, California, 미국, 92868
- UCI Medical Center
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Sacramento, California, 미국, 95817
- University California, Davis
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San Diego, California, 미국, 92103
- University of California San Diego (UCSD) Medical Center
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Colorado
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Denver, Colorado, 미국, 80204
- Ernest E Moore Shock Trauma Center at Denver Health
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Florida
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Jacksonville, Florida, 미국, 32209
- UF Health Jacksonville
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Miami, Florida, 미국, 33136
- Ryder Trauma Center
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Miami, Florida, 미국, 33136
- Jackson South Medical Center
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Tampa, Florida, 미국, 33606
- Tampa General Hospital
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Georgia
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Atlanta, Georgia, 미국, 30303
- Grady Memorial Hospital
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Bayview Medical Center
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Baltimore, Maryland, 미국, 21201
- R Adams Cowley Baltimore Shock Trauma
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, 미국, 63110
- Saint Louis University (SLU)
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New Jersey
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Camden, New Jersey, 미국, 08103
- Cooper University Hospital
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Newark, New Jersey, 미국, 07103
- Rutgers New Jersey Medical School
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Hospital
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest School of Medicine
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Winston-Salem, North Carolina, 미국, 27157
- Atrium Health Wake Forest Baptist Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University Hospital
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Philadelphia, Pennsylvania, 미국, 19104
- Penn Presbyterian Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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Texas
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Austin, Texas, 미국, 78701
- The University of Texas - Dell Medical School
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Beersheba, 이스라엘, 8410101
- Soroka Medical Center - Vascular Surgery Department
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 생명 또는 사지를 위협하는 심장 이외의 사지 또는 몸통의 동맥 혈관에 대한 외상성 손상으로 교체 또는 재건이 필요한 환자
- 수술 전 영상 또는 임상 검사에서 손상된 혈관의 결함 길이가 ≤ 38cm이고 혈관 수축 및 상황에 따른 유입 및 유출 고려 사항을 고려하여 치료 외과의의 판단에 따라 6mm 인간 무세포 혈관(HAV)에 적절하게 크기가 일치하는 것으로 나타납니다.
- 자가 정맥 이식은 치료하는 외과의의 판단에 적합하지 않거나(예: 적합한 도관의 가용성 부족, 심각한 정맥 기능 부전의 존재) 혈관재생술의 긴급성 때문에 바람직하지 않습니다.
- 18세 이상 85세 이하
- 조사 직원과 의미 있는 의사소통이 가능하고 전체 연구 절차를 준수할 수 있습니다. 환자가 의식이 없는 경우 신뢰할 수 있는 증인의 정보는 환자가 일반적으로 연구 절차를 따를 수 있음을 나타냅니다.
- 환자 또는 친척이 정보에 입각한 동의를 제공할 능력, 의지 및 능력이 있음
- 기대 수명 최소 1년
제외 기준:
- 망가진 사지 심각도 점수(MESS) ≥ 7
- 혈관 재건에도 불구하고 절단 위험이 높은 사지(예: 압박 손상으로 인해)
- 생존 가능성을 떨어뜨리는 치명적인 부상(예: 약식 상해 척도(AIS) > 5 또는 상해 심각도 점수(ISS) >60)
- HAV는 관상 동맥 복구에 사용할 수 없습니다.
- 알려진 임산부
- 급성 손상이 해결된 후 장기간의 항혈소판제 요법을 배제할 것으로 알려진 의학적 상태
- 조사관의 판단에 따라 HAV의 안전성 및 효능에 대한 적절한 평가를 방해하는 기타 조건
- HAV에 대한 이전 노출
- 지난 30일 이내에 조사 연구에 알려진 참여
- 후원자의 직원 또는 연구자의 직원 또는 친척인 환자
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
기간: 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.
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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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
기간: 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).
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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
기간: 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
기간: 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
기간: 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
기간: 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.
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 36 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 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
기간: 36 months from time of implantation
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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
기간: 36 months from time of implantation
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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.
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36 months from time of implantation
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Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
기간: 36 months from implantation
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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
기간: 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
기간: 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.
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12 months from time of implantation
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HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
기간: 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
기간: 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).
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30 days from time of implantation
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HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Shamik Parikh, MD, Humacyte, Inc.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2018년 9월 1일
기본 완료 (실제)
기본 완료
2023년 9월 19일
연구 완료 (실제)
연구 완료
2026년 5월 15일
연구 등록 날짜
최초 제출
최초 제출
2016년 12월 21일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2016년 12월 23일
처음 게시됨 (추정된)
처음 게시됨
2016년 12월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 1일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CLN-PRO-V005
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .