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Study protocol for paradigm shift in vascular access creation: The VAC study.
Hou Guocun1,2, Mi Lanhua1, Bian Fan3
1Department of Vascular Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
The Journal of Vascular Access
|February 27, 2025
Summary
The modified RADAR technique for radiocephalic fistula creation shows promise. This study compares its clinical outcomes against the conventional technique in a large randomized trial.
Area of Science:
- Vascular Surgery
- Nephrology
- Clinical Trials
Background:
- The conventional radial artery deviation and reimplantation (RADAR) technique uses an end-to-side artery-to-vein configuration.
- A modified RADAR (M-RADAR) technique has been developed, featuring a side-to-side anastomosis and ligation of the distal cephalic vein.
- The VAC Study is a multicenter randomized controlled trial comparing M-RADAR with the conventional technique for radiocephalic fistula creation.
Purpose of the Study:
- To compare the clinical outcomes of radiocephalic arteriovenous fistula (AVF) created using the modified RADAR (M-RADAR) technique versus the conventional technique (CT).
- To provide clear guidance for clinicians on optimal cephalic vein treatment strategies during AVF surgery.
Main Methods:
- Prospective, multicenter, randomized study initiated in December 2024 with ongoing participant recruitment.
- Data collection via paper-based Case Report Forms (CRFs).
- An estimated 408 participants will be recruited from approximately 29 dialysis units across China.
Main Results:
- Primary endpoints: 1-year primary patency rate of AVF and incidence of venous juxta-anastomotic stenosis.
- Secondary endpoints: 1-year access-assisted primary patency, access cumulative patency, hospitalization rates, mortality, and economic cost analysis.
- The study is currently in the recruitment phase, with no results available yet.
Conclusions:
- A high-quality, adequately powered multicenter randomized controlled trial is necessary.
- This trial aims to offer definitive evidence for selecting the optimal surgical technique for radiocephalic AVF.
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