Clinical Research Directory

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

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.

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.