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Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair

NCT07762794 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-08-13

No results posted yet for this study

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.

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.

Conditions

  • Vascular Injury
  • Arterial Injury
  • Trauma Injury

Interventions

BIOLOGICAL

Acellular Tissue Engineered Vessel

Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess

Sponsors & Collaborators

  • Humacyte, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-09-30
Completion
2030-09-30
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 NCT07762794 on ClinicalTrials.gov