Peng Gao1, Zhenwei Zhao2, Daming Wang3, Jian Wu4, Yiling Cai5, Tianxiao Li6, Wei Wu7, Huaizhang Shi8, Weiwen He9, Fengshui Zhu1, Liqun Jiao10, Feng Ling1. 1. Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China. 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. 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. 10. Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, China liqunjiao@sina.cn.
Abstract
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.
RCT Entities:
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.
Authors: Colin P Derdeyn; David Fiorella; Michael J Lynn; Zoran Rumboldt; Harry J Cloft; Daniel Gibson; Tanya N Turan; Bethany F Lane; L Scott Janis; Marc I Chimowitz Journal: Neurosurgery Date: 2013-05 Impact factor: 4.654
Authors: Helmi L Lutsep; Stanley L Barnwell; Darren T Larsen; Michael J Lynn; Mindy Hong; Tanya N Turan; Colin P Derdeyn; David Fiorella; L Scott Janis; Marc I Chimowitz Journal: Stroke Date: 2015-01-15 Impact factor: 7.914
Authors: David Fiorella; Elad I Levy; Aquilla S Turk; Felipe C Albuquerque; David B Niemann; Beverly Aagaard-Kienitz; Ricardo A Hanel; Henry Woo; Peter A Rasmussen; L Nelson Hopkins; Thomas J Masaryk; Cameron G McDougall Journal: Stroke Date: 2007-02-08 Impact factor: 7.914
Authors: P Gao; D Wang; Z Zhao; Y Cai; T Li; H Shi; W Wu; W He; L Yin; S Huang; F Zhu; L Jiao; X Ji; A I Qureshi; F Ling Journal: AJNR Am J Neuroradiol Date: 2016-02-11 Impact factor: 3.825
Authors: Marios Psychogios; Alex Brehm; Elena López-Cancio; Gian Marco De Marchis; Elena Meseguer; Aristeidis H Katsanos; Christine Kremer; Peter Sporns; Marialuisa Zedde; Adam Kobayashi; Jildaz Caroff; Daniel Bos; Sabrina Lémeret; Avtar Lal; Juan F Arenillas Journal: Eur Stroke J Date: 2022-06-03