An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.

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.

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Key information

Conditions

Vascular Trauma Arterial Bleeding Arterial Injury Wounds and Injuries

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

a. 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

Exclusion criteria

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

Treatment and study plan

Acellular Tissue Engineered Vessel (Symvess)

Biological

ATEV

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Warren Prosser

CONTACT

[email protected]

919-313-9633

Sponsors and collaborators

Lead sponsor

Humacyte, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 13, 2026
Registry last updated: Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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