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NCT07762313

PHASE3

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

Sponsor: Humacyte, Inc.

View on ClinicalTrials.gov

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. 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.

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.

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Vascular Trauma Arterial Injury Arterial Bleeding

Interventions

BIOLOGICAL

Acellular Tissue Engineered Vessel (Symvess)

ATEV

Inclusion Criteria: 1. 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 2. Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss 3. 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 4. 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 5. Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits. 6. 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 7. Life expectancy of at least 1 year based on clinical assessment by the Investigator Exclusion Criteria: 1. Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7 2. Injury Severity Score (ISS) \>60 3. Known pregnant females 4. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries 5. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS 6. Previous exposure to SYMVESS 7. Known participation in any investigational study within the last 30 days 8. Employees of the sponsor or patients who are employees or relatives of the Investigator