Qi Yuhan, Zhang Huawei, Zhao Jichun, Yuan Ding, Wang Jiarong, Ge Jinting, Huang Bin, Weng Chengxin, Wang Tiehao
Division of Vascular Surgery, Department of General Surgery, West China Hospital, Sichuan University, Sichuan Province, China.
West China School of Medicine, Sichuan University, Chengdu, China.
BMJ Open. 2024 Aug 7;14(8):e080560. doi: 10.1136/bmjopen-2023-080560.
Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents.
The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure.
Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number: 2023-1186). The results will be submitted to a major clinical journal for peer review and publication.
ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).
血管内治疗已成为治疗股腘动脉外周动脉疾病的一项重要策略，与开放手术旁路移植术相比，其安全性和有效性可接受。与裸金属支架相比，紫杉醇洗脱支架和肝素涂层支架均显示出更好的临床疗效。然而，目前缺乏比较紫杉醇洗脱支架和肝素涂层支架安全性和有效性的一级证据。因此，本研究的主要目的是系统评价这两种支架的疗效和安全性。
ELITE试验是一项前瞻性、多中心、平行、随机对照试验。共招募450例患者。研究的主要终点包括首次手术后1年的原发性通畅率。
本研究已获得四川大学华西医院伦理委员会的伦理批准（批准号：2023-1186）。研究结果将提交给一本主要的临床杂志进行同行评审和发表。
ELITE试验于2023年9月27日在中国临床试验注册中心注册（注册号：ChiCTR2300076236）。
