Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Human Acellular Vessel · 4 trials · 7 indications
Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio \>70% during any session in which 2 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration." The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.
Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation. The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency. Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
Primary patency = patent ("open" to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions
| Arm | Type | Description |
|---|---|---|
| Human Acellular Vessel (HAV) | EXPERIMENTAL | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0. |
| Arteriovenous fistula (AVF) | ACTIVE_COMPARATOR | The comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0. |
| ePTFE | ACTIVE_COMPARATOR | One of two commercially available comparators (Bard Impra® and Gore PROPATEN®) |
| HAV Treatment | EXPERIMENTAL | Human Acellular Vessel (HAV) |
| Name | Type | Description |
|---|---|---|
| Human Acellular Vessel (HAV) | BIOLOGICAL | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
| Arteriovenous fistula (AVF) | PROCEDURE | Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
| Hemodialysis | OTHER | Procedure that filters a person's blood when their kidneys are no longer functioning properly |
| ePTFE graft | DEVICE | One of two commercially available comparators (Bard Impra® and Gore PROPATEN®) |
Inclusion Criteria: 1. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access. 2. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after...