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
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.
An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass