To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Public ClinicalTrials.gov record NCT05908084. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized Study to Compare the Efficacy and Safety of the Humacyte Acellular Tissue Engineered Vessel (ATEV) With That of an Autogenous Arteriovenous Fistula (AVF) in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).
Study identification
- NCT ID
- NCT05908084
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2023 (Actual)
- Primary completion
- Jun 2027 (Estimated)
- Completion
- Jun 2028 (Estimated)
- Last update posted
- Jun 26, 2026
2023 – 2028
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health Scottsdale Shea Medical Center | Scottsdale | Arizona | 85260 | — |
| El Centro Regional Medical Center | El Centro | California | 92243 | — |
| Jacob's Medical Center at UC San Diego Health | La Jolla | California | 92037 | — |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | — |
| Access Research Institute | Brooksville | Florida | 34613 | — |
| University of FL Health Heart and Vascular Hospital | Gainesville | Florida | 32608 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| American Access Care of Miami, LLC | Miami | Florida | 33156 | — |
| USF Health South Tampa | Tampa | Florida | 33606 | — |
| Georgia Nephrology | Atlanta | Georgia | 30046 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| IU Health Bloomington Hospital | Bloomington | Indiana | 47408 | — |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Rutgers University_Medical | Newark | New Jersey | 07103 | — |
| St.Joseph's University Medical Center | Paterson | New Jersey | 07503 | — |
| Capital Health Medical Center- Hopewell | Pennington | New Jersey | 08534 | — |
| New York-Presbyterian Queens_The Lang Center for Research & Education | Flushing | New York | 11355 | — |
| Ambulatory Care Pavilion Westchester Medical Center | Valhalla | New York | 10595 | — |
| Surgical Specialists of Charlotte | Charlotte | North Carolina | 28207 | — |
| Duke Regional Hospital | Durham | North Carolina | 27704 | — |
| Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Dell Seton Medical Center at The University of Texas at Austin | Austin | Texas | 78701 | — |
| Dr. Ruben Villa__Nephrology | Lubbock | Texas | 79407 | — |
| Cataract & Surgery Center Lubbock | Lubbock | Texas | 79410 | — |
| San Antonio Vascular and Endovascular Clinic PLLC | San Antonio | Texas | 78221 | — |
| The San Antonio Vascular and Endovascular Clinic | San Antonio | Texas | 78221 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05908084, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05908084 live on ClinicalTrials.gov.