Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma (NCT03005418) | Clinical Trial Compass
CompletedPhase 2/3
Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma
United States, Israel72 participantsStarted 2018-09-01
Plain-language summary
This study evaluates the use of the Acellular Tissue Engineered Vessel (ATEV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be an extremity cohort and an torso cohort. All subjects will be implanted with an ATEV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
Who can participate
Age range
18 Years – 85 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:
* Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
* Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
* Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization
* Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
* Patient or relative is able, willing and competent to give informed consent
* Life expectancy of at least 1 year
Exclusion Criteria:
* Mangled Extremity Severity Score (MESS) of ≥ 7
* Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
* Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \> 5 or Injury Severity Score (ISS) \>60)
* ATEV may not be used for coronary artery repair
* …
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.
What they're measuring
1
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group
Timeframe: 30 days from time of implantation
2
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup