Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Acellular Tissue Engineered Vessel (ATEV), Acellular Tissue Engineered Vessel, Acellular Tissue Engineered Vessel (Symvess)
Symvess · 3 trials · 6 indications
Adverse Events including serious, events of special interest, and death will be assessed in the overall study population
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining ATEV patency through the 12-month follow-up period, evaluated across the entire overall study population.
Time-to-event analysis estimating the long-term cumulative probabilities of amputation-free ATEV rate through the 12-month follow-up period, evaluated across the entire overall study population.
Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free ATEV rates through the 12-month follow-up period, evaluated across the entire overall study population.
To determine the number of days free from indwelling catheter (catheter-free days) since randomization to 365 days (Month 12), or until SA abandonment, whichever occurs first.
To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.
Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
| Arm | Type | Description |
|---|---|---|
| Symvess | EXPERIMENTAL | - |
| ATEV treatment arm | EXPERIMENTAL | ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm |
| AVF treatment arm | ACTIVE_COMPARATOR | AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm |
| Acellular Tissue Engineered Vessel (ATEV) | EXPERIMENTAL | Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques. |
| Name | Type | Description |
|---|---|---|
| Acellular Tissue Engineered Vessel (Symvess) | BIOLOGICAL | ATEV |
| Acellular Tissue Engineered Vessel (ATEV) | BIOLOGICAL | ATEV implantation |
| AVF | OTHER | AVF creation procedure |
Inclusion Criteria: 1. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator a. For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends...