Abstract
Background
Arteriovenous fistula (AVF) is the preferred type of vascular access for maintenance hemodialysis (MHD) patients. Stenosis is the main cause of AVF dysfunction. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. This trial aims to determine: the effect of using paclitaxel release balloons combined with PCSK9 inhibitors on improving postoperative patency of AVF and the safety of combined use.
Methods
This is a prospective, randomized, controlled study. It is exploratory research. The study will recruit 40 MHD patients aged from 18 to 75 years, with an intervention period of 48 weeks. Patients will be randomized into two arms: (1) The treatment group received postoperative use of 140 mg of Ribavirin, subcutaneously administered every two weeks for a total of 48 weeks. (2) Control group no Intervention. The primary outcome is the main patency rate.
Discussion
This is an exploratory study which would be conducted to evaluate the efficacy and safety of PCSK9 inhibitors in the patency of AVF after paclitaxel release balloon surgery. Expected to improve restenosis rate and extend the service life of AVF.
Trial registration
The trial is approved by Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (LY2023-113-A). Written informed consent in the local language is obtained from each participant before conducting any study-related procedure. Results will be shared with the local community and internationally with academic and policy stakeholders.
Clinical trials ID
NCT06034691
09/10/2023