Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Pati… (NCT07762794) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
125 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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