Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, China.
Department of Biomechanics and Rehabilitation Engineering, Capital Medical University, Beijing, China.
BMJ Open. 2022 Mar 23;12(3):e059401. doi: 10.1136/bmjopen-2021-059401.
The multibranched off-the-shelf stent graft is a promising treatment option for thoracoabdominal aortic aneurysm (TAAA). A commercially available, multibranched, off-the-shelf endograft called the t-Branch stent graft has demonstrated favourable midterm outcomes. Another two investigational off-the-shelf endografts, the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis and E-nside multibranch stent graft system, are still being developed. However, these three endografts have an unsatisfactory anatomic feasibility rate in patients with TAAA. Based on the concept of Guo's renovisceral artery reconstruction-1, a novel, multibranched, off-the-shelf endograft with different configurations has been developed.
This prospective, multicentre, single-arm, cohort study will enrol 73 patients with TAAA. Preoperative and postoperative clinical data, as well as CT angiography images at each follow-up timepoint, will be analysed to evaluate the safety and efficacy of this novel, multibranched, off-the-shelf endograft for the treatment of TAAA. The primary safety end point is the major adverse event rate within 30 days after index endovascular aortic repair, including all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, cardiac infarction and respiratory failure. The primary efficacy end point is the successful treatment rate within 12 months after procedure, which is a composite of immediate technical success and no secondary surgical intervention related to TAAA within 12 months after the procedure.
The protocol has been reviewed and approved by the ethics committee of Chinese PLA General Hospital (reference number: 2021-NO.-007) and each participating hospital. The findings of this study will be disseminated through conference presentations, peer-reviewed journal publications and social media.
NCT05054985.
分支型非定制支架移植物是治疗胸腹主动脉瘤（TAAA）的一种很有前途的治疗选择。一种商用的、多分支的、非定制的支架移植物，称为 t-Branch 支架移植物，已经显示出良好的中期结果。另外两种正在研究中的非定制支架移植物，GORE EXCLUDER 胸腹主动脉分支型覆膜支架和 E-nside 多分支支架移植物系统，仍在开发中。然而，这三种支架移植物在 TAAA 患者中的解剖可行性率并不令人满意。基于 Guo 的内脏动脉重建-1 的概念，开发了一种新型的、多分支的、非定制的、具有不同构型的支架移植物。
这是一项前瞻性、多中心、单臂、队列研究，将纳入 73 例 TAAA 患者。将分析术前和术后的临床数据以及每次随访时的 CT 血管造影图像，以评估这种新型的、多分支的、非定制的支架移植物治疗 TAAA 的安全性和疗效。主要安全性终点是指数血管内主动脉修复后 30 天内的主要不良事件发生率，包括全因死亡、肝功能衰竭、肠坏死、肾衰竭、中风、永久性截瘫、心肌梗死和呼吸衰竭。主要疗效终点是术后 12 个月内的成功治疗率，这是即时技术成功和术后 12 个月内无与 TAAA 相关的二次手术干预的综合指标。
该方案已由中国人民解放军总医院伦理委员会（编号：2021-NO.-007）和每个参与医院审查和批准。本研究的结果将通过会议演讲、同行评议期刊发表和社交媒体传播。
NCT05054985。
