Vascular TraumaPhase 3NCT07762313
An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.
A Phase 3 study testing Acellular Tissue Engineered Vessel (Symvess) in people with Vascular Trauma and Arterial Injury, run by Humacyte, Inc..
Trial summary
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Vascular Trauma, Arterial Injury, Arterial Bleeding
- What is being tested?
- Acellular Tissue Engineered Vessel (Symvess)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator
- For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends beyond the inguinal crease onto the thigh
- Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss
- Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS 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) or is not desirable because of the urgency of revascularization
- Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits.
- Patient is able and willing to provide informed assent and parent (or legal representative) is able and willing to provide informed consent prior to treatment with SYMVESS
- Life expectancy of at least 1 year based on clinical assessment by the Investigator
Who cannot join
- Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7
- Injury Severity Score (ISS) >60
- Known pregnant females
- Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS
- Previous exposure to SYMVESS
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multi-center, Open-label Study, to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury When Autologous Vein Graft is Not Feasible.
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available.
The main questions the study aims to answer are:
Read more
Safety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free
Participants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.
Read the detailed description
A prospective, multi-center, open-label study, to assess the safety and efficacy of SYMVESS® as a vascular conduit for repair of extremity arterial injury in adolescents (age 17 years or younger) who have reached adult sexual maturity (Tanner Sexual Maturity Rating Stage 5). Eligible participants will require urgent revascularization to avoid imminent limb loss, and autologous vein graft is not feasible. Participants will return for routine follow-up visits up to 12-months post implantation.
- Conditions
- Vascular Trauma, Arterial Injury, Arterial Bleeding
- Being tested
- Acellular Tissue Engineered Vessel (Symvess)
- Keywords
- Symvess, Trauma, Adolescents, Arterial injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Tissue Engineered Vessel (Symvess)Biological
ATEV
| Study group | Role | What they receive |
|---|---|---|
| Symvess | Experimental | Not described Receives: Biological: Acellular Tissue Engineered Vessel (Symvess) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events
Adverse Events including serious, events of special interest, and death will be assessed in the overall study population
Measured: 12 months
Kaplan-Meier estimated patency
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining ATEV patency through the 12-month follow-up period, evaluated across the entire overall study population.
Measured: 12 months
Kaplan-Meier estimated amputation-free rate
Time-to-event analysis estimating the long-term cumulative probabilities of amputation-free ATEV rate through the 12-month follow-up period, evaluated across the entire overall study population.
Measured: 12 months
Kaplan-Meier estimated infection-free rate
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free ATEV rates through the 12-month follow-up period, evaluated across the entire overall study population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762313
- Sponsor's protocol ID
- CLN-PRO-V019
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-label Study, to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury When Autologous Vein Graft is Not Feasible.
- ClinicalTrials.gov ID
- NCT07762313
- Acronym / sponsor ID
- CLN-PRO-V019
- Conditions
- Vascular Trauma, Arterial Injury, Arterial Bleeding
- Keywords
- Symvess, Trauma, Adolescents, Arterial injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available.
The main questions the study aims to answer are:
Safety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free
Participants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.
Detailed description
A prospective, multi-center, open-label study, to assess the safety and efficacy of SYMVESS® as a vascular conduit for repair of extremity arterial injury in adolescents (age 17 years or younger) who have reached adult sexual maturity (Tanner Sexual Maturity Rating Stage 5). Eligible participants will require urgent revascularization to avoid imminent limb loss, and autologous vein graft is not feasible. Participants will return for routine follow-up visits up to 12-months post implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symvess | Experimental | Biological: Acellular Tissue Engineered Vessel (Symvess) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator
- Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss
- Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS 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) or is not desirable because of the urgency of revascularization
- Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits.
Key exclusion criteria (8 listed)
- Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7
- Injury Severity Score (ISS) >60
- Known pregnant females
- Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS
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 (Symvess)ATEV | Biological | Symvess |
Primary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: 12 months
Adverse Events including serious, events of special interest, and death will be assessed in the overall study population
Kaplan-Meier estimated patency
Time frame: 12 months
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining ATEV patency through the 12-month follow-up period, evaluated across the entire overall study population.
Kaplan-Meier estimated amputation-free rate
Time frame: 12 months
Time-to-event analysis estimating the long-term cumulative probabilities of amputation-free ATEV rate through the 12-month follow-up period, evaluated across the entire overall study population.
Kaplan-Meier estimated infection-free rate
Time frame: 12 months
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free ATEV rates through the 12-month follow-up period, evaluated across the entire overall study population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acellular Tissue Engineered Vessel (Symvess) in people with Vascular Trauma and Arterial Injury, run by Humacyte, Inc..
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Prosser (919-313-9633, wprosser@humacyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.