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.
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)
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)
Single group
Acellular Tissue Engineered Vessel
Biological/VaccineHumacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess
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.
Kaplan-Meier estimated limb salvage rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess limb salvage rates through the 12-month follow-up period evaluated across the entire study population.
Kaplan-Meier estimated Symvess infection-free rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess infection free rates through the 12-month follow-up period evaluated across the entire study population.
Kaplan-Meier estimated Symvess primary patency
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess primary patency through the 12-month follow-up period evaluated across the entire study population.
Rate and frequency of Treatment Emergent Adverse Events
Safety events will be assessed including all treatment emergent adverse events, serious adverse events (SAEs), and adverse events of interest (AESIs).
Kaplan-Meier estimated MALE-free rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess MALE-free rate through the 12-month follow-up period evaluated across the entire study population.
Kaplan Meier estimated Symvess integrity rate
Time-to-event analysis estimating the long-term cumulative probabilities of Symvess integrity rate through the 12-month follow-up period evaluated across the entire study population. The loss of mechanical integrity of Symvess is defined as rupture or anastomotic dehiscence
Rate of in-hospital events
The rate of in-hospital events (e.g., major amputation of the index limb, Symvess conduit infection, loss of Symvess secondary patency) prior to discharge.
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