Hou Guocun, Mi Lanhua, Bian Fan, Chen Dongping, Chang Guangqi, Chen Jilin, Cheng Xiaojuan, Feng Jian, Fan Xueqiang, He Jianqiang, He Qiang, Huang Jian, Jiang Hua, Liu Bin, Liao Dan, Li Chuan, Liu Zongyang, Lu Mingxi, Li Xiuyong, Tang Chenquan, Wang Siwen, Wang Pei, Xu Liyun, Xun Kang, Ye Xiaowen, Yin Fei, Yuan Liang, Ye Zhiming, Zhang Lihong, Zhao Lingfeng, Zhan Shen, Zhang Yaling, Shi Yaxue
{"title":"Study protocol for paradigm shift in vascular access creation: The VAC study.","authors":"Hou Guocun, Mi Lanhua, Bian Fan, Chen Dongping, Chang Guangqi, Chen Jilin, Cheng Xiaojuan, Feng Jian, Fan Xueqiang, He Jianqiang, He Qiang, Huang Jian, Jiang Hua, Liu Bin, Liao Dan, Li Chuan, Liu Zongyang, Lu Mingxi, Li Xiuyong, Tang Chenquan, Wang Siwen, Wang Pei, Xu Liyun, Xun Kang, Ye Xiaowen, Yin Fei, Yuan Liang, Ye Zhiming, Zhang Lihong, Zhao Lingfeng, Zhan Shen, Zhang Yaling, Shi Yaxue","doi":"10.1177/11297298251321983","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>Registration number: ChiCTR2400093537, Registered on 2024-12-06.</p>","PeriodicalId":56113,"journal":{"name":"Journal of Vascular Access","volume":" ","pages":"2067-2075"},"PeriodicalIF":1.7000,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Vascular Access","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/11297298251321983","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/26 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
The Journal of Vascular Access (JVA) is issued six times per year; it considers the publication of original manuscripts dealing with clinical and laboratory investigations in the fast growing field of vascular access. In addition reviews, case reports and clinical trials are welcome, as well as papers dedicated to more practical aspects covering new devices and techniques.
All contributions, coming from all over the world, undergo the peer-review process.
The Journal of Vascular Access is divided into independent sections, each led by Editors of the highest scientific level:
• Dialysis
• Oncology
• Interventional radiology
• Nutrition
• Nursing
• Intensive care
Correspondence related to published papers is also welcome.
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