A Phase 4 interventional study of Acellular Tissue Engineered Vessel in Vascular Injury, Arterial Injury and Trauma Injury, sponsored by Humacyte, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Humacyte, Inc. · Phase 4, Interventional, and Treatment
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.
A Phase 4, observational, multicenter, non-randomized, open-label post-marketing study in patients treated with commercially available Symvess for injuries to upper and lower extremities.
All eligible patients treated with Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI. Eligible patients will be adults suitable for treatment with Symvess as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
Patients will be implanted with a Symvess as an interposition replacement or bypass using standard vascular surgical techniques. At least one anastomosis should be distal to or within the Axillary artery if repair is in upper extremity and either distal to or within the Femoral artery, if repair is in lower extremity.
Patients with injuries limited to the vessels of the heart, head and neck area or exclusively within the torso are not eligible for the study.
Each patient will be followed for up to 12 months post implantation. Post-implant assessments include the following:
27 studies on the registry are indexed under Vascular System Injuries; 8 are open to participants now.
This study's planned enrollment of 125 is above the median of 60 across 17 interventional studies indexed under Vascular System Injuries.
Browse Vascular System Injuries studies →Humacyte, Inc. is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI
Exclusion Criteria:
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Symvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury
Biological: Acellular Tissue Engineered Vessel
Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess
Also known as: ATEV, 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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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).
Time frame: 12 months
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.
Time frame: 12 months
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
Time frame: 12 months
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.
Time frame: Perioperative (during hospitalization for index surgery)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2030, 48 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human acellular vessel extra-cellular matrix