Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05908084 | To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis | PHASE3 | RECRUITING | 150 | — | — | Sep 7, 2023 | Oct 1, 2027 | Mar 18, 2025 | 32 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV) | BIOLOGICAL | ATEV implantation |
| AVF | OTHER | AVF creation procedure |
Inclusion Criteria: 1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access. 2. Patients who plan to undergo HD at a dialysis unit of a particip...