A Phase 3 interventional study of Acellular Tissue Engineered Vessel (Symvess) in Vascular Trauma, Arterial Injury and Arterial Bleeding, sponsored by Humacyte, Inc.. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Humacyte, Inc. · Phase 3, Interventional, and Treatment
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.
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.
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
Exclusion Criteria:
Biological: Acellular Tissue Engineered Vessel (Symvess)
ATEV
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Humacyte, Inc.