China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China
机构:[1]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China神经外科首都医科大学宣武医院[2]Department of Neurosurgery, Tangdu Hospital, the Fourth Military Medical University, China[3]Department of Neurosurgery, Beijing Hospital of the Ministry of Health, China[4]Department of Neurology, Xuanwu Hospital, Capital Medical University, China神经内科首都医科大学宣武医院[5]Department of Neurology, the 306 Hospital of PLA, China[6]Department of Intervention, Henan Provincial People’s Hospital, China[7]Department of Neurology, Qilu Hospital of Shandong University, China[8]Department of Neurosurgery, The 1st Affiliated Hospital of Harbin Medical University, China[9]Department of Neurology, The 2nd Affiliated Hospital of Guangzhou Medical College, 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. Conclusion: 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.
基金:
National Health and Family Planning Commission of the People's Republic of China [2011BAI08B04]
语种:
外文
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2014]版:
大类|4 区医学
小类|4 区临床神经病学4 区核医学
最新[2023]版:
大类|4 区医学
小类|4 区临床神经病学4 区核医学
JCR分区:
出版当年[2013]版:
Q4CLINICAL NEUROLOGYQ4RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
最新[2023]版:
Q3CLINICAL NEUROLOGYQ3RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGINGQ4CLINICAL NEUROLOGY
第一作者机构:[1]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China
通讯作者:
通讯机构:[*1]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Beijing 100053, China.
推荐引用方式(GB/T 7714):
Peng Gao,Zhenwei Zhao,Daming Wang,et al.China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China[J].INTERVENTIONAL NEURORADIOLOGY.2015,21(2):196-204.doi:10.1177/1591019915581778.
APA:
Peng Gao,Zhenwei Zhao,Daming Wang,Jian Wu,Yiling Cai...&Feng Ling.(2015).China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China.INTERVENTIONAL NEURORADIOLOGY,21,(2)
MLA:
Peng Gao,et al."China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China".INTERVENTIONAL NEURORADIOLOGY 21..2(2015):196-204