TY - JOUR T1 - Selection criteria for large core trials: rationale for the ANGEL-ASPECT study design JF - Journal of NeuroInterventional Surgery JO - J NeuroIntervent Surg DO - 10.1136/neurintsurg-2021-017798 SP - neurintsurg-2021-017798 AU - Zeguang Ren AU - Xiaochuan Huo AU - Gaoting Ma AU - Xu Tong AU - Jay Kumar AU - Elliot Pressman AU - Wenhuo Chen AU - Guangxiong Yuan AU - Alvin Yi-Chou Wang AU - Ming Wei AU - Jiangang Zhang AU - Guangxian Nan AU - Qiyi Zhu AU - Yajie Liu AU - Liyong Zhang AU - Weigen Song AU - Zhiming Zhou AU - Guoqing Wang AU - Tianxiao Li AU - Jun Luo AU - En Wang AU - Wentong Ling AU - Dongsheng Ju AU - Cunfeng Song AU - Shu-Dong Liu AU - Liqiang Gui AU - Tong Li AU - Yan Liu AU - Junfeng Zhao AU - Zaiyu Guo AU - Hongbo Zheng AU - Yaxuan Sun AU - Na Xu AU - Yong Jun Wang AU - Zhongrong Miao A2 - , Y1 - 2021/07/29 UR - http://jnis.bmj.com/content/early/2021/07/29/neurintsurg-2021-017798.abstract N2 - Two recently published JNIS commentaries1 2 on eligibility criteria for the clinical trials on patients with large core, acute ischemic stroke (AIS) with large vessel occlusion have caused some debate. Five trials were included.1 Our ongoing trial, ANGEL-ASPECT (NCT 04551664), which represents the only large core trial currently ongoing in the Chinese population, was not included in the discussion. One issue of the debate is the addition of CT perfusion (CTP)/diffusion-weighted image of magnetic resonance imaging (DWI-MRI) to the inclusion criteria, which only the SELECT-2 trial chose to adopt. This raised concern about whether patients already known to benefit from endovascular thrombectomy (EVT) are being randomized to EVT treatment or no treatment. Like the SELECT-2 trial, our ANGEL-ASPECT trial also added CTP/DWI-MRI to our inclusion criteria, but in a manner different from SELECT-2. Here we review the merits of ANGEL-ASPECT’s design and suggest that it be included in the discussion of patient selection criteria in large core trials.The ANGEL-ASPECT trial is an ongoing, multicenter, randomized controlled trial (RCT) currently being conducted in China and sponsored by Beijing Tiantan Hospital. Patients are enrolled according to a prespecified protocol. Each randomized patient is qualified by two core laboratory members who are available at all hours to calculate Alberta Stroke Program Early CT Score (ASPECTS) and infarct core volume using the specialized RAPID software.As for the other five trials discussed in the commentary by Jadhav et al,1 the primary goal of our trial is to determine whether EVT will benefit or harm patients with AIS and large vessel occlusion and a ‘large core’ infarct. While the ANGEL-ASPECT and SELECT-2 trials both include core volume as defined by CTP in the inclusion criteria in addition to ASPECTS, the other four trials define large core using only ASPECTS. The … ER -