TraumaPhase 2/3NCT03005418
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
A Phase 2/3 study testing Acellular Tissue Engineered Vessel (ATEV) in people with Trauma and Vascular System Injury, run by Humacyte, Inc. at 29 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Trauma, Vascular System Injury
- What is being tested?
- Acellular Tissue Engineered Vessel (ATEV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 1 Sep 2018to 15 May 2026
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
The University of Texas - Dell Medical School
Austin, Texas, 78701
R Adams Cowley Baltimore Shock Trauma
Baltimore, Maryland, 21201
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Cooper University Hospital
Camden, New Jersey, 08103
Ernest E Moore Shock Trauma Center at Denver Health
Denver, Colorado, 80204
Duke University Hospital
Durham, North Carolina, 27705
UF Health Jacksonville
Jacksonville, Florida, 32209
Jacob Medical Center at UC San Diego
La Jolla, California, 92037
Keck Hospital of University of Southern California (USC)
Los Angeles, California, 90033
Cedars-Sinai Medical Cener
Los Angeles, California, 90048
Jackson South Medical Center
Miami, Florida, 33136
Ryder Trauma Center
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
UCI Medical Center
Orange, California, 92868
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University California, Davis
Sacramento, California, 95817
University of California San Diego (UCSD) Medical Center
San Diego, California, 92103
Saint Louis University (SLU)
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
Israel2 sites
Soroka Medical Center - Vascular Surgery Department
Beersheba, 8410101
Shaare Zedek Medical Center
Jerusalem, 9103102
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Trauma, Vascular System Injury
- Being tested
- Acellular Tissue Engineered Vessel (ATEV)
- Medical subject headings
- Wounds and Injuries, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Tissue Engineered Vessel (ATEV)Biological
Also called Human Acellular Vessel (HAV)
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.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV) | Experimental | 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. Receives: Biological: Acellular Tissue Engineered Vessel (ATEV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
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.
Measured: 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
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.
Measured: 30 days from time implantation
Secondary outcomes (34)
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
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).
Measured: 30 days from time of implantation
HAV Infection Free Rate at Day 30 in the All HAV Group
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.
Measured: 30 days from time of implantation
Limb Salvage Rate at Day 30 in the All HAV Group
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.
Measured: 30 Days from time of implantation
Survival Rate at Day 30 in the All HAV Group
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.
Measured: 30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
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.
Measured: 12 months from implantation
Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
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.
Measured: 36 months from implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 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
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).
Measured: 30 days from time of implantation
HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 30 days from time of implantation
Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 30 Days from time of implantation
Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 12 months from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 36 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
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.
Measured: 36 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.
Measured: 36 months from time of implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Sep 2018
- Primary completion19 Sep 2023
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Shamik Parikh, MD, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005418
- Sponsor's protocol ID
- CLN-PRO-V005
- Status last verified
- Jul 2026
- First submitted
- 21 Dec 2016
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41140335Moore 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.
PubMed 39565635
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03005418
- Acronym / sponsor ID
- CLN-PRO-V005
- Conditions
- Trauma, Vascular System Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group, U.S. Army Medical Research and Development Command
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV) | Experimental | Biological: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Life expectancy of at least 1 year
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV)Also: Human Acellular Vessel (HAV)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. | Biological | Acellular Tissue Engineered Vessel (ATEV) |
Primary outcome
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Time frame: 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
Time frame: 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.
34 secondary outcomes
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Time frame: 30 days from time of implantation
HAV Infection Free Rate at Day 30 in the All HAV Group
Time frame: 30 days from time of implantation
Limb Salvage Rate at Day 30 in the All HAV Group
Time frame: 30 Days from time of implantation
Survival Rate at Day 30 in the All HAV Group
Time frame: 30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group
Time frame: 12 months from time of implantation
Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group
Time frame: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
Time frame: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
Time frame: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
Time frame: 12 months from implantation
Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group
Time frame: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group
Time frame: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group
Time frame: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group
Time frame: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group
Time frame: 36 months from implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Time frame: 30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Time frame: 12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group
Time frame: 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
Time frame: 30 days from time of implantation
HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Time frame: 30 days from time of implantation
Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Time frame: 30 Days from time of implantation
Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup
Time frame: 30 Days from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
Time frame: 12 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
Time frame: 12 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
Time frame: 12 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
Time frame: 12 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
Time frame: 12 months from time of implantation
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup
Time frame: 36 months from time of implantation
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup
Time frame: 36 months from time of implantation
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup
Time frame: 36 months from time of implantation
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup
Time frame: 36 months from time of implantation
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup
Time frame: 36 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Time frame: 30 days from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Time frame: 12 months from time of implantation
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup
Time frame: 36 months from time of implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41140335Lum 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.
- Derived from this study: PubMed 39565635Moore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamik Parikh, MD study director
Humacyte, Inc.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acellular Tissue Engineered Vessel (ATEV) in people with Trauma and Vascular System Injury, run by Humacyte, Inc. at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group (time frame: 30 days from time of implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005418, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.