Can a Lab-Grown artery save injured limbs?
NCT ID NCT07762794
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study is testing a lab-grown blood vessel called Symvess in adults who have suffered a serious injury to an artery in their arm or leg. The goal is to see how well the vessel stays open and functions over a year, and whether it helps avoid amputation and infection. Participants will receive Symvess during surgery and will be followed for up to 12 months with imaging and check-ups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Symvess (Acellular Tissue Engineered Vessel), a lab-grown blood vessel used to replace or repair damaged arteries
- What this could lead to
- If successful, this could confirm that Symvess is a reliable, infection-resistant option for repairing severe limb artery injuries, potentially reducing amputations and improving recovery.
- What could go wrong
- This is an observational study without a comparison group, so results may be influenced by other factors. Risks include possible vessel blockage, infection, or need for additional surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged at least 18 years old 2. Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI 1. 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) 2. 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) 3. Patient or legal representative is able, willing, and competent to give informed consent. 4. Patient's life expectancy is at least 1 year based on the judgement of the Investigator 5. 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 6. Patient must have confirmed health insurance Exclusion Criteria: 1. Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization 2. Patients lacking enough healthy muscle and/or soft tissue for adequate coverage of Symvess 3. Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up a. Positive screen for illicit drugs (THC use is not exclusionary) 4. Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders) 5. Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up 6. Employee of the Sponsor or patient who is an employee or relative of the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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