Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-02 @ 4:37 AM
Study NCT ID:
NCT04376567
Status:
TERMINATED
Last Update Posted:
2025-09-11
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
Sponsor:
Tze-Woei Tan
Organization:
Study Overview
Official Title:
Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI is leaving the institution and the trial will be not resuming.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.
Detailed Description:
The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: