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

NCT07762313 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Vascular Trauma
  • Arterial Injury
  • Arterial Bleeding

Interventions

BIOLOGICAL

Acellular Tissue Engineered Vessel (Symvess)

ATEV

Sponsors & Collaborators

  • Humacyte, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762313 on ClinicalTrials.gov