Clinical Research Directory
Browse clinical research sites, groups, and studies.
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
Sponsor: Humacyte, Inc.
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.
Official title: A Phase 4 Observational Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting for Arterial Replacement or Reconstruction in Patients With Extremity Vascular Trauma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2026-09
Completion Date
2030-09
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
Acellular Tissue Engineered Vessel
Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess