TY - JOUR
T1 - Study protocol for a Prospective, Randomized controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenOsis in dysfunctional arteRio-venous fistulas (PREDATOR)
AU - Gan, Chye Chung
AU - Tan, Ru Yu
AU - Delaney, Christopher L.
AU - Puckridge, Phillip J.
AU - Pang, Suh Chien
AU - Tng, Alvin Ren Kwang
AU - Tan, Chee Wooi
AU - Tan, Chieh Suai
AU - Tan, Alfred Bingchao
AU - Zhuang, Kun Da
AU - Gogna, Apoorva
AU - Tay, Kiang Hiong
AU - Chan, Sze Ling
AU - Yap, Charyl Jia Qi
AU - Chong, Tze Tec
AU - Tang, Tjun Yip
PY - 2024/3
Y1 - 2024/3
N2 - Background: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. Methods: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. Discussion: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.
AB - Background: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. Methods: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. Discussion: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.
KW - angioplasty
KW - arteriovenous fistula
KW - Cephalic arch stenosis
KW - paclitaxel
KW - stent graft
UR - http://www.scopus.com/inward/record.url?scp=85141418791&partnerID=8YFLogxK
U2 - 10.1177/11297298221130897
DO - 10.1177/11297298221130897
M3 - Article
C2 - 36330556
AN - SCOPUS:85141418791
SN - 1129-7298
VL - 25
SP - 625
EP - 632
JO - Journal of Vascular Access
JF - Journal of Vascular Access
IS - 2
ER -