Vascular InjuryPhase 4NCT07762794
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
A Phase 4 study testing Acellular Tissue Engineered Vessel in people with Vascular Injury and Arterial Injury, run by Humacyte, Inc..
Trial summary
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury. The primary objective of the study is to determine Symvess secondary patency at 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Injury, Arterial Injury, Trauma Injury
- What is being tested?
- Acellular Tissue Engineered Vessel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged at least 18 years old
- Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI
- Symvess implant is to be used to re-establish blood flow to one of the major extremity arteries (see Section 4.1 for examples of size appropriate vessels)
- Although the proximal anastomosis may originate in the upper or lower torso region, the distal anastomosis must terminate in the extremity (e.g., below the inguinal crease for lower extremity, in the axillary or more distal in the upper extremity)
- Patient or legal representative is able, willing, and competent to give informed consent.
- Patient's life expectancy is at least 1 year based on the judgement of the Investigator
- Patient must have a home or place of residence whereby he/she may be contacted and a support system which would make them suitable for this study of one year follow-up duration
- Patient must have confirmed health insurance
Who cannot join
- Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization
- Patients lacking enough healthy muscle and/or soft tissue for adequate coverage of Symvess
- Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up
- Positive screen for illicit drugs (THC use is not exclusionary)
- Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders)
- Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up
- Employee of the Sponsor or patient who is an employee or relative 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 Phase 4 Observational Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting for Arterial Replacement or Reconstruction in Patients With Extremity Vascular Trauma
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
The primary objective of the study is to determine Symvess secondary patency at 1 year.
Read more
Additional key secondary objectives, such as limb salvage, infection-free rate, primary patency, and safety, will also be assessed at 1 year.
All participants will receive Symvess. This is an open-label study and there is no comparator.
Participants will undergo surgery to repair an extremity arterial injury using Symvess. Participants will be asked to return at regular intervals up to 1 year post-implant to undergo imaging to assess Symvess patency, and for other standard clinical safety and efficacy assessments.
Read the detailed description
A Phase 4, observational, multicenter, non-randomized, open-label post-marketing study in patients treated with commercially available Symvess for injuries to upper and lower extremities.
All eligible patients treated with Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI. Eligible patients will be adults suitable for treatment with Symvess as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
Patients will be implanted with a Symvess as an interposition replacement or bypass using standard vascular surgical techniques. At least one anastomosis should be distal to or within the Axillary artery if repair is in upper extremity and either distal to or within the Femoral artery, if repair is in lower extremity.
Patients with injuries limited to the vessels of the heart, head and neck area or exclusively within the torso are not eligible for the study.
Each patient will be followed for up to 12 months post implantation. Post-implant assessments include the following:
- Full Physical Exam including surgical site
- Focused Vascular Assessment
- Clinical examination of the Symvess implant site
- Duplex Ultrasound to confirm patency of Symvess
- Documentation of any Symvess interventions
- Confirmation of compliance with antiplatelet therapy
- Concomitant Medications
- Assessment of Adverse Events
- Conditions
- Vascular Injury, Arterial Injury, Trauma Injury
- Being tested
- Acellular Tissue Engineered Vessel
- Keywords
- Trauma, Extremity arterial injury, Symvess, Arterial injury, Vascular injury, Trauma injury
- Medical subject headings
- Vascular System Injuries, Accidental Injuries, 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 VesselBiological
Also called ATEV, Symvess
Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess
| Study group | Role | What they receive |
|---|---|---|
| Symvess | Other | Symvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury Receives: Biological: Acellular Tissue Engineered Vessel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier estimated Symvess secondary patency
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess secondary patency through the 12-month follow-up period evaluated across the entire study population.
Measured: 12 months
Secondary outcomes (4)
Kaplan-Meier estimated limb salvage rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess limb salvage rates through the 12-month follow-up period evaluated across the entire study population.
Measured: 12 months
Kaplan-Meier estimated Symvess infection-free rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess infection free rates through the 12-month follow-up period evaluated across the entire study population.
Measured: 12 months
Kaplan-Meier estimated Symvess primary patency
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess primary patency through the 12-month follow-up period evaluated across the entire study population.
Measured: 12 months
Rate and frequency of Treatment Emergent Adverse Events
Safety events will be assessed including all treatment emergent adverse events, serious adverse events (SAEs), and adverse events of interest (AESIs).
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 completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 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
- NCT07762794
- Sponsor's protocol ID
- CLN-PRO-V020
- Status last verified
- Aug 2026
- First submitted
- 7 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 Phase 4 Observational Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting for Arterial Replacement or Reconstruction in Patients With Extremity Vascular Trauma
- ClinicalTrials.gov ID
- NCT07762794
- Acronym / sponsor ID
- CLN-PRO-V020
- Conditions
- Vascular Injury, Arterial Injury, Trauma Injury
- Keywords
- Trauma, Extremity arterial injury, Symvess, Arterial injury, Vascular injury, Trauma injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (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 post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
The primary objective of the study is to determine Symvess secondary patency at 1 year.
Additional key secondary objectives, such as limb salvage, infection-free rate, primary patency, and safety, will also be assessed at 1 year.
All participants will receive Symvess. This is an open-label study and there is no comparator.
Participants will undergo surgery to repair an extremity arterial injury using Symvess. Participants will be asked to return at regular intervals up to 1 year post-implant to undergo imaging to assess Symvess patency, and for other standard clinical safety and efficacy assessments.
Detailed description
A Phase 4, observational, multicenter, non-randomized, open-label post-marketing study in patients treated with commercially available Symvess for injuries to upper and lower extremities.
All eligible patients treated with Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI. Eligible patients will be adults suitable for treatment with Symvess as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
Patients will be implanted with a Symvess as an interposition replacement or bypass using standard vascular surgical techniques. At least one anastomosis should be distal to or within the Axillary artery if repair is in upper extremity and either distal to or within the Femoral artery, if repair is in lower extremity.
Patients with injuries limited to the vessels of the heart, head and neck area or exclusively within the torso are not eligible for the study.
Each patient will be followed for up to 12 months post implantation. Post-implant assessments include the following:
- Full Physical Exam including surgical site
- Focused Vascular Assessment
- Clinical examination of the Symvess implant site
- Duplex Ultrasound to confirm patency of Symvess
- Documentation of any Symvess interventions
- Confirmation of compliance with antiplatelet therapy
- Concomitant Medications
- Assessment of Adverse Events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symvess | Other | Biological: Acellular Tissue Engineered VesselSymvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged at least 18 years old
- Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI
- Patient or legal representative is able, willing, and competent to give informed consent.
- Patient's life expectancy is at least 1 year based on the judgement of the Investigator
- Patient must have a home or place of residence whereby he/she may be contacted and a support system which would make them suitable for this study of one year follow-up duration
Key exclusion criteria (7 listed)
- Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization
- Patients lacking enough healthy muscle and/or soft tissue for adequate coverage of Symvess
- Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up
- Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders)
- Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up
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 VesselAlso: ATEV, SymvessHumacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess | Biological | Symvess |
Primary outcome
Kaplan-Meier estimated Symvess secondary patency
Time frame: 12 months
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess secondary patency through the 12-month follow-up period evaluated across the entire study population.
4 secondary outcomes
Kaplan-Meier estimated limb salvage rate
Time frame: 12 months
Kaplan-Meier estimated Symvess infection-free rate
Time frame: 12 months
Kaplan-Meier estimated Symvess primary patency
Time frame: 12 months
Rate and frequency of Treatment Emergent Adverse Events
Time frame: 12 months
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 4 study testing Acellular Tissue Engineered Vessel in people with Vascular Injury 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 7 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Kaplan-Meier estimated Symvess secondary patency (time frame: 12 months). 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.