China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China.
BACKGROUND
Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer 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 natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria.


METHODS
The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. 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 as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. 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. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019.


CONCLUSIONS
In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers.
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China.
Peng
P
Gao
Department of Neurosurgery, Tangdu Hospital, the Fourth Military Medical University, China.
Zhenwei
Z
Zhao
Department of Neurosurgery, Beijing Hospital of the Ministry of Health, China.
Daming
D
Wang
Department of Neurology, Xuanwu Hospital, Capital Medical University, China.
Jian
J
Wu
Department of Neurology, the 306 Hospital of PLA, China.
Yiling
Y
Cai
Department of Intervention, Henan Provincial People's Hospital, China.
Tianxiao
T
Li
Department of Neurology, Qilu Hospital of Shandong University, China.
Wei
W
Wu
Department of Neurosurgery, The 1st Affiliated Hospital of Harbin Medical University, China.
Huaizhang
H
Shi
Department of Neurology, The 2nd Affiliated Hospital of Guangzhou Medical College, China.
Weiwen
W
He
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China.
Fengshui
F
Zhu
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China liqunjiao@sina.cn.
Liqun
L
Jiao
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China.
Feng
F
Ling
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D002539:Cerebral Arterial Diseases / Q000150:complications / Q000601:surgery*; D002681:China; D003251:Constriction, Pathologic; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000601:surgery
Atherosclerosis; China; angioplasty and stenting; intracranial stenosis; stroke