NCT07762794

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
49mo left

Started Sep 2026

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

4 years

First QC Date

August 7, 2026

Last Update Submit

August 11, 2026

Conditions

Vascular InjuryArterial InjuryTrauma Injury

Keywords

TraumaExtremity arterial injurySymvessArterial injuryVascular injuryTrauma injury

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier estimated Symvess secondary patency

    Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess secondary patency through the 12-month follow-up period evaluated across the entire study population.

    12 months

Secondary Outcomes (4)

  • Kaplan-Meier estimated limb salvage rate

    12 months

  • Kaplan-Meier estimated Symvess infection-free rate

    12 months

  • Kaplan-Meier estimated Symvess primary patency

    12 months

  • Rate and frequency of Treatment Emergent Adverse Events

    12 months

Other Outcomes (3)

  • Kaplan-Meier estimated MALE-free rate

    12 months

  • Kaplan Meier estimated Symvess integrity rate

    12 months

  • Rate of in-hospital events

    Perioperative (during hospitalization for index surgery)

Study Arms (1)

Symvess

OTHER

Symvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury

Biological: Acellular Tissue Engineered Vessel

Interventions

Acellular Tissue Engineered VesselBIOLOGICAL

Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess

Also known as: ATEV, Symvess
Symvess

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged at least 18 years old
  • Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI
  • Symvess implant is to be used to re-establish blood flow to one of the major extremity arteries (see Section 4.1 for examples of size appropriate vessels)
  • Although the proximal anastomosis may originate in the upper or lower torso region, the distal anastomosis must terminate in the extremity (e.g., below the inguinal crease for lower extremity, in the axillary or more distal in the upper extremity)
  • Patient or legal representative is able, willing, and competent to give informed consent.
  • Patient's life expectancy is at least 1 year based on the judgement of the Investigator
  • Patient must have a home or place of residence whereby he/she may be contacted and a support system which would make them suitable for this study of one year follow-up duration
  • Patient must have confirmed health insurance

You may not qualify if:

  • Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization
  • Patients lacking enough healthy muscle and/or soft tissue for adequate coverage of Symvess
  • Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up
  • Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders)
  • Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up
  • Employee of the Sponsor or patient who is an employee or relative of the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular System InjuriesAccidental InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Warren Prosser

CONTACT

919-313-9633wprosser@humacyte.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share