Kidney Week

Abstract: SA-PO1103

Interim Outcomes of China's First Independently Developed Expanded Polytetrafluoroethylene (ePTFE) Graft for Hemodialysis Vascular Access

Session Information

• Kidney Replacement Therapy and Care Delivery Innovations
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Luo, Yuan, Center for Kidney Diseases, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Yuan Luo, MD

• Bian, Xueqin, Center for Kidney Diseases, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Xueqin Bian, MD

• Yang, Xiaoyan, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China

Xiaoyan Yang, PhD

• Liu, Zongyang, Guizhou Medical University Affiliated Cancer Hospital, Guiyang, Guizhou, China

Zongyang Liu

• Liu, Yangdong, South China Hospital of Shenzhen University, Shenzhen, Guangdong, China

Yangdong Liu, MD

• Yan, Yan, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

Yan Yan, MD

• Ye, Hong, Center for Kidney Diseases, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Hong Ye, MD

Background

Arteriovenous grafts are essential for maintenance hemodialysis patients unsuitable for autogenous fistula creation. We report interim outcomes of CoreVascu, China's first independently developed ePTFE graft for hemodialysis access.

Methods

In this prospective, multicenter, randomized, active-controlled, non-inferiority trial, eligible patients requiring upper-extremity graft creation were randomized 1:1 to CoreVascu (Jiangxi Sanxin Medtec Co., Ltd.) or the active comparator (GORE INTERING ePTFE graft). Co-primary endpoints were 6-month primary unassisted patency and 12-month cumulative patency. Secondary endpoints included 3-month primary patency, procedural success, suturability, time to first cannulation, and adverse events.

Results

As of April 15, 2026, 131 patients were enrolled (CoreVascu: 62; comparator: 69). Fifty-four completed 3-month and 29 completed 6-month follow-up; none reached 12-month follow-up. Baseline characteristics and time to first cannulation were comparable between groups (33.63±4.81 vs. 34.95±5.47 days). Primary unassisted patency was higher with CoreVascu at 3 months (93.1% vs. 92.0%) and 6 months (66.7% vs. 64.3%). Procedural success was 100% in both groups, and all grafts were easy to suture. Adverse events (37 vs. 38) and serious adverse events (14 vs. 12) showed no significant differences. No device defects were reported.

Conclusion

In this interim analysis, CoreVascu demonstrated higher observed 3- and 6-month primary unassisted patency compared to the GORE INTERING ePTFE graft. Procedural success, suturability, cannulation feasibility, and adverse event profiles were comparable between groups. Longer follow-up is required to assess 12-month cumulative patency and confirm non-inferiority.

Funding

• Government Support – Non-U.S.