准分子激光消融联合药物涂层球囊与药物涂层球囊治疗下肢新发病变粥样硬化（ELABORATE）：一项真实世界临床试验的研究方案。
Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial.
机构信息
Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Department of Vascular Surgery, Qingpu Branch of Zhongshan Hospital, Fudan University, 1158 East Gongyuan Road, Shanghai, 201715, China.
出版信息
BMC Cardiovasc Disord. 2022 Jul 16;22(1):317. doi: 10.1186/s12872-022-02751-1.
BACKGROUND
The efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized.
METHODS
ELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD.
DISCUSSION
ELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years. Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx .
背景
准分子激光消融（ELA）在支架内再狭窄（ISR）中的疗效和有效性已得到证实。然而，其在下肢动脉疾病（LEAD）新出现的动脉粥样硬化病变中的应用尚未明确，其操作也尚未标准化。
方法
ELABORATE 是一项前瞻性、多中心、真实世界研究，旨在评估 ELA 联合药物涂层球囊（DCB）与单独 DCB 治疗 LEAD 新出现动脉粥样硬化病变的疗效和安全性。
讨论
ELABORATE 是一项前瞻性、多中心、真实世界研究，旨在评估 ELA 联合药物涂层球囊（DCB）与单独 DCB 治疗 LEAD 新出现动脉粥样硬化病变患者的疗效和安全性。根据真实情况，将符合条件的患者分配到 ELA+DCB 组（E 组）和 DCB 组（C 组）。收集基线和随访信息（3、6 和 12 个月）。主要疗效终点为 12 个月时的原发性通畅率，次要疗效终点包括临床驱动的靶病变再介入（CD-TLR）、Rutherford 分级变化、踝肱指数和溃疡愈合率。这些指标将在 3、6 和 12 个月的随访中进行评估和记录。此外，还将通过独立核心实验室评估安全性评估，包括 30 天随访时的主要不良事件、全因死亡率、计划性大截肢、挽救性支架和远端栓塞。所有数据将通过电子数据采集系统收集和记录。该研究将于 3 年内完成，将于 2023 年获得 12 个月的结果。所有患者将随访 5 年。试验注册号：中国临床试验注册中心（ChiCTR2100051263）。登记日期：2019 年 9 月 17 日。http://www.chictr.org.cn/listbycreater.aspx。
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