de Donato Gianmarco, Pasqui Edoardo, Giannace Giovanni, Setacci Francesco, Benevento Domenico, Palasciano Giancarlo, Setacci Carlo
Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Multimedica, Milan, Italy.
JMIR Res Protoc. 2019 Mar 14;8(3):e9972. doi: 10.2196/resprot.9972.
Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.
The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month.
The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.
These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/9972.
急性下肢缺血（ALLI）对肢体存活构成重大威胁。多年来，外科血栓切除术一直是主要的治疗方法。近年来，血管内治疗给ALLI的管理带来了一场革命。新设计的血管内血栓切除术装置似乎可能使治疗建议转向血管内治疗方案。本方案研究旨在收集支持最新假设的证据。
所研究的装置是Penumbra/Indigo系统（Penumbra公司）。本临床研究的目的是在可控环境下评估该装置的早期安全性和有效性，并确定在确诊为外周急性闭塞的患者中使用这些系统的最佳技术。
本研究将是一项对诊断为ALLI并接受Penumbra/Indigo装置治疗的患者进行的前瞻性干预试验。该项目旨在成为一个全国性平台，每位受邀参与的医生都可以登记自己的数据和操作。主要结局是使用Indigo系统进行血栓抽吸的技术成功率。在使用该装置前后，将使用心肌梗死溶栓（TIMI）评分分类记录血管通畅情况的评估。随访时的临床成功定义为与术前Rutherford分类相比，在1个月随访时Rutherford分类改善一级或更多。次要终点包括：（1）出院时的安全率，定义为无任何严重不良事件；（2）1个月时的初级通畅率，定义为在双功超声检查中目标病变无血流动力学显著狭窄或再闭塞（>50%）且在1个月内无需对目标病变进行再次干预；（3）1个月时的肢体挽救情况。
该研究目前处于招募阶段，预计最后一名患者将于2019年3月底接受治疗。总共将招募150名患者。分析将集中在主要和次要终点。
这些专门为这类困难患者的外周干预而设计的新型血管内血栓切除术装置，如拟议登记处正在研究的那些装置，可能会提供更好的临床结局，同时降低主要全身和局部并发症的发生率。本研究完成后，预计将更好地确定Indigo血栓切除术系统在治疗ALLI中的价值。因此，在不久的将来可能会观察到治疗建议向血管内治疗方案的转变。
国际注册报告识别码（IRRID）：DERR1-10.2196/9972。
