Gan, Chye Chung and Tan, Ru Yu and Delaney, Christopher L. and Puckridge, Phillip J. and Pang, Suh Chien and Tng, Alvin Ren Kwang and Tan, Chee Wooi and Tan, Chieh Suai and Tan, Alfred Bingchao and Da Zhuang, Kun and Gogna, Apoorva and Tay, Kiang Hiong and Chan, Sze Ling and Yap, Charyl Jia Qi and Chong, Tze Tec and Tang, Tjun Yip (2024) Study protocol for a Prospective, Randomized Controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenORsis in dysfunctional arteio-venous fistulas (PREDATOR). Journal of Vascular Access, 25 (2). pp. 625-632. ISSN 1129-7298, DOI https://doi.org/10.1177/11297298221130897.
Full text not available from this repository.Abstract
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.
| Item Type: | Article |
|---|---|
| Funders: | BD (Franklin Lakes, New Jersey, USA) |
| Uncontrolled Keywords: | Cephalic arch stenosis; stent graft; paclitaxel; angioplasty; arteriovenous fistula |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 15 Nov 2024 02:41 |
| Last Modified: | 15 Nov 2024 02:41 |
| URI: | http://eprints.um.edu.my/id/eprint/46090 |
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