Abstract 64: China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A Prospective, Multicenter, Randomized Controlled Trial After SAMMPRIS

作者：Peng, Gao; Liqun, Jiao; Yan, Ma; Yabing, Wang; Yanfei, Chen; Zhenwei, Zhao; Daming, Wang; Yiling, Cai; Wei, Wu; Tianxiao, Li; Huaizhang, Shi; Weiwen, He

来源：Stroke, 2018, 49(Suppl_1).

DOI：10.1161/str.49.suppl_1.64

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<jats:bold>Background:</jats:bold>
Patients with symptomatic stenosis of intracranial arteries are at high risk for future stroke. Since the SAMMPRIS trial, stenting is not recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we propose a refined prospective, randomised, multicenter study in a Chinese population with strictly defined patient and participating center inclusion criteria.
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<jats:bold>Methods:</jats:bold>
The CASSISS trial is an ongoing, government-funded, prospective, multicenter trial (NCT01763320). It recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients. For practice, CASSISS has been divided into 2 stages: lead-in and randomised phase. The lead-in trial recruited 100 consecutive patients for Wingpsan stent placement from July 2013 to February 2014 among 13 sites in China. The overall 1-month stroke and/or death rate was 2%, which demonstrated modifications in patient selection and procedural aspects can substantially reduce peri-procedural rate. The randomised phase started on Mar 2014, a total of 380 patients was randomised (1:1) to best medical therapy alone or medical therapy plus stenting among 8 sites in China. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. Recruitment has been finished on November 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019.
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<jats:bold>Conclusion:</jats:bold>
The prospective multicenter single-arm trial has demonstrated acceptable results. The 1-year follow-up of the 380 patients will be finished in November 2017. We expect that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers.
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• 出版日期2018-1-22