Study protocol for paradigm shift in vascular access creation: The VAC study.

BACKGROUND

The radial artery deviation and reimplantation (RADAR) technique uses an artery-to-vein (end-to-side) configuration. We have developed a modified RADAR (M-RADAR) technique. This new technique enables a side-to-side anastomosis between the vessels, and furthermore, the distal cephalic vein is ligated. The VAC Study (Paradigm Shift in Vascular Access Creation) is a multicenter randomized controlled trial comparing the clinical outcomes of radiocephalic fistula created using the conventional technique (CT group) versus the modified RADAR method (M-RADAR group).

METHODS

Prospective, multicenter, randomized study starting in December 2024. Participant recruitment has commenced. All data are collected via paper-based Case Report Forms (CRFs). The primary clinical endpoints include the 1-year primary patency rate of AVF and the incidence of venous juxta-anastomotic stenosis. Secondary endpoints include the 1-year access-assisted primary patency, access cumulative patency, hospitalization rates, mortality, and an analysis of the economic costs associated with maintaining vascular access. An estimated 408 participants will be recruited from approximately 29 dialysis units across China.

DISCUSSION: A high-quality, adequately powered multicenter randomized controlled trial (RCT) is still needed to provide clear guidance for clinicians on selecting optimal treatment strategies for the cephalic vein during AVF surgery.

TRIAL REGISTRATION: Registration number: ChiCTR2400093537, Registered on 2024-12-06.