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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04135417 | Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis | PHASE2 | COMPLETED | 30 | — | — | Nov 12, 2019 | Mar 2, 2022 | Mar 19, 2024 | 2 | Poland |
Frequency and severity of AEs of each patient will be documented
Assess changes in the PRA response (number of participants) over the 2 months after graft implantation
Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.
| Arm | Type | Description |
|---|---|---|
| HAV | EXPERIMENTAL | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator. |
| Name | Type | Description |
|---|---|---|
| HAV | BIOLOGICAL | Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. |
Inclusion Criteria: 1. Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper or forearm) for hemodialysis therapy. 2. Already established on hemodialysis 3. At least 18 years of age at S...