Study Results
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Basic Information
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COMPLETED
NA
217 participants
INTERVENTIONAL
2016-07-31
2022-06-30
Brief Summary
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Detailed Description
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Subject Population: Subjects presenting with acute ischemic stroke within 6-24 hours from symptom onset/last seen well and whose strokes are attributable to an occlusion of the basilar artery. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. The randomization employs a 1:1 ratio of mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration versus medical management alone. Randomization will be done under a stratification process using age, baseline National Institute of Health Stroke Scale (NIHSS) and therapeutic window. For the primary endpoint, subjects will be followed for 90 days post-randomization.Sample size is projected to be 318 patients.
Care providers: Vascular neurologists and trained interventional neuroradiologists or neurologists in certified comprehensive stroke centers that treat more than 500 acute stroke patients and perform more than 30 acute mechanical thrombectomies every year will treat patients. Neurointerventionalists have to have previously performed at least 10 thrombectomies with Solitaire device in acute ischemic stroke patients.
Interventions: Patients in both arms will be admitted at acute stroke units (or Intensive Care Unit if needed) and treated following the Chinese Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Concomitant medications and non-pharmacological therapies will be recorded. If a decision of stopping support life measures is adopted, this will be recorded in the Case Report Form (CRF).A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion angioplasty/stenting through detachment of the Solitaire device will be allowed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Endovascular Arm
Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
Best Medical Treatment and maximum supportive care
Mechanical embolectomy
Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
Medical Treatment
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Control Arm
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Medical Treatment
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Interventions
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Mechanical embolectomy
Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
Medical Treatment
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Eligibility Criteria
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Inclusion Criteria
2. Occlusion (Thrombolysis in Myocardial Infarction, TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries as evidenced by computed tomography (CT) angiography, magnetic resonance (MR) angiography or angiogram.
3. Age ≥18 and ≤80 years.
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score obtained prior to randomization must be equal to or higher than 6 points.
5. No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
6. Patient treatable within 24 hours from time last seen well. Isolated vertigo with nausea and/or vomiting is not considered onset of symptom.
7. Informed consent obtained from patient or acceptable patient surrogate.
Exclusion Criteria
2. Baseline platelet count \< 50.000/µL.
3. Baseline blood glucose \< 50mg/dL or \> 400mg/dL.
4. Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg).
5. Patients in sedation and/or intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life threatening allergy (more than rash) to contrast medium
9. Subjects who has received i.v. tissue plasminogen activator (t-PA) treatment beyond 4.5 hours from the beginning of the symptoms.
10. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery (beyond 48h they should be randomized in BAOCHE or excluded for endovascular treatment if poor medical conditions).
11. Renal insufficiency with creatinine ≥ 3 mg/dl.
12. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
13. Subject participating in a study involving an investigational drug or device that would impact this study.
14. Cerebral vasculitis.
15. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations; mRS score at baseline must be ≤ 1.
16. Unlikely to be available for 90 days follow-up.
1. Hypodensity amounting to a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \< 6 and Pons-midbrain-index of ≥ 3 on CT angiography source images or MR with diffusion-weighted imaging or NCCT.
2. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
3. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
4. Complete unilateral or bilateral thalamic infarction on CT or MRI
5. Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
6. Subjects with occlusions in both anterior and posterior circulation.
7. Evidence of intracranial tumor (except small meningioma).
18 Years
80 Years
ALL
No
Sponsors
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Zhangzhou Municipal Hospital of Fujian Province
OTHER
The First People's Hospital of Changzhou
OTHER
Xinqiao Hospital of Chongqing
OTHER
Changhai Hospital
OTHER
Baotou Central Hospital
OTHER
904th Hospital of the Joint Logistics Support Force of the PLA
OTHER
Linyi People's Hospital
OTHER
The 985 Hospital of PLA, Taiyuan, Shanxi
UNKNOWN
The First Affiliated Hospital with Nanjing Medical University
OTHER
Tianjin TEDA Hospital
UNKNOWN
Liaocheng People's Hospital
OTHER
Luoyang Central Hospital
OTHER
Subei People's Hospital of Jiangsu Province
OTHER
PLA 148 Hospital, Zibo, Shandong
UNKNOWN
Hebei General Hospital
OTHER
Shengli Oilfield Hospital
OTHER
Shenzhen Bao'an District People's Hospital
UNKNOWN
The First Hospital of Jilin University
OTHER
Henan Provincial People's Hospital
OTHER
Peking University Binhai Hospital
UNKNOWN
Beijing Tiantan Hospital
OTHER
The Military General Hospital of Beijing, PLA
UNKNOWN
The First Affiliated Hospital of Shanxi Medical University
OTHER
Beijing Luhe Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Nanning Second People's Hospital
OTHER
Chongqing Three Gorges Central Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
The Fifth Central Hospital of Tianjin,TianJin
UNKNOWN
Yantaishan Hospital
UNKNOWN
Nanyang Central Hospital
OTHER
Second Affiliated Hospital of Soochow University
OTHER
Tianjin Huanhu Hospital
OTHER
The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital
UNKNOWN
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Principal Investigators
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Xunming Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Tudor G Jovin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburg Medical Center Stroke
Locations
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Baotou Central Hospital
Baotou, , China
Beijing Luhe Hospital
Beijing, , China
Beijing Tiantan Hospital
Beijing, , China
The Military General Hospital of Beijing, PLA
Beijing, , China
Xuanwu Hospital
Beijing, , China
The First People's Hospital of Changzhou
Changzhou, , China
Chongqing Three Gorges Central Hospital
Chongqing, , China
Xinqiao Hospital of Chongqing
Chongqing, , China
Shengli Oilfield Hospital
Dongying, , China
The Affiliated Hospital Of Guizhou Medical University
Guiyang, , China
First Hospital of Jilin University
Jilin, , China
Liaocheng Third People's Hospital
Liaocheng, , China
Linyi People's Hospital
Linyi, , China
Luoyang Central Hospital
Luoyang, , China
Nanjing First People's Hospital
Nanjing, , China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, , China
Nanning Second People's Hospital
Nanning, , China
Nantong University
Nantong, , China
Nanyang Central Hospital
Nanyang, , China
Changhai Hospital
Shanghai, , China
Shenzhen Bao'an District People's Hospital
Shenzhen, , China
Hebei General Hospital
Shijiazhuang, , China
Second Affiliated Hospital of Soochow University
Suzhou, , China
PLA 264 Hospital
Taiyuan, , China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, , China
Peking University Binhai Hospital
Tianjin, , China
The Fifth Central Hospital of Tianjin
Tianjin, , China
Tianjin Huanhu Hospital
Tianjin, , China
Tianjin TEDA Hospital
Tianjin, , China
The 101st Hospital of Chinese People's Liberation Army
Wuxi, , China
The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital
Xi'an, , China
Subei People's Hospital of Jiangsu Province
Yangzhou, , China
Yantaishan Hospital
Yantai, , China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, , China
Henan Provincial Hospital
Zhengzhou, , China
PLA 148 Hospital
Zibo, , China
Countries
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References
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Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B, Barr J, Dillon W, Warach S, Broderick J, Tilley B, Sacks D; Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiology; Technology Assessment Committee of the Society of Interventional Radiology. Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke. 2003 Aug;34(8):e109-37. doi: 10.1161/01.STR.0000082721.62796.09. Epub 2003 Jul 17.
Liu X, Dai Q, Ye R, Zi W, Liu Y, Wang H, Zhu W, Ma M, Yin Q, Li M, Fan X, Sun W, Han Y, Lv Q, Liu R, Yang D, Shi Z, Zheng D, Deng X, Wan Y, Wang Z, Geng Y, Chen X, Zhou Z, Liao G, Jin P, Liu Y, Liu X, Zhang M, Zhou F, Shi H, Zhang Y, Guo F, Yin C, Niu G, Zhang M, Cai X, Zhu Q, Chen Z, Liang Y, Li B, Lin M, Wang W, Xu H, Fu X, Liu W, Tian X, Gong Z, Shi H, Wang C, Lv P, Tao Z, Zhu L, Yang S, Hu W, Jiang P, Liebeskind DS, Pereira VM, Leung T, Yan B, Davis S, Xu G, Nogueira RG; BEST Trial Investigators. Endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST): an open-label, randomised controlled trial. Lancet Neurol. 2020 Feb;19(2):115-122. doi: 10.1016/S1474-4422(19)30395-3. Epub 2019 Dec 9.
Writing Group for the BASILAR Group; Zi W, Qiu Z, Wu D, Li F, Liu H, Liu W, Huang W, Shi Z, Bai Y, Liu Z, Wang L, Yang S, Pu J, Wen C, Wang S, Zhu Q, Chen W, Yin C, Lin M, Qi L, Zhong Y, Wang Z, Wu W, Chen H, Yao X, Xiong F, Zeng G, Zhou Z, Wu Z, Wan Y, Peng H, Li B, Hu X, Wen H, Zhong W, Wang L, Jin P, Guo F, Han J, Fu X, Ai Z, Tian X, Feng X, Sun B, Huang Z, Li W, Zhou P, Tu M, Sun X, Li H, He W, Qiu T, Yuan Z, Yue C, Yang J, Luo W, Gong Z, Shuai J, Nogueira RG, Yang Q. Assessment of Endovascular Treatment for Acute Basilar Artery Occlusion via a Nationwide Prospective Registry. JAMA Neurol. 2020 May 1;77(5):561-573. doi: 10.1001/jamaneurol.2020.0156.
Jovin TG, Li C, Wu L, Wu C, Chen J, Jiang C, Shi Z, Gao Z, Song C, Chen W, Peng Y, Yao C, Wei M, Li T, Wei L, Xiao G, Yang H, Ren M, Duan J, Liu X, Yang Q, Liu Y, Zhu Q, Shi W, Zhu Q, Li X, Guo Z, Yang Q, Hou C, Zhao W, Ma Q, Zhang Y, Jiao L, Zhang H, Liebeskind DS, Liang H, Jadhav AP, Wen C, Brown S, Zhu L, Ye H, Ribo M, Chang M, Song H, Chen J, Ji X; BAOCHE Investigators. Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1373-1384. doi: 10.1056/NEJMoa2207576.
Hankey GJ. Endovascular Therapy for Acute Basilar Artery Occlusion. Circulation. 2022 Jul 5;146(1):18-20. doi: 10.1161/CIRCULATIONAHA.122.060571. Epub 2022 Jul 5. No abstract available.
Li C, Wu C, Wu L, Zhao W, Chen J, Ren M, Yao C, Yan X, Dong C, Song H, Ma Q, Duan J, Zhang Y, Zhang H, Jiao L, Wang Y, Jovin TG, Ji X; BAOCHE Investigators. Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a prospective randomized controlled study. Int J Stroke. 2022 Jul;17(6):694-697. doi: 10.1177/17474930211040923. Epub 2021 Aug 28.
Other Identifiers
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Xuanwu201601
Identifier Type: -
Identifier Source: org_study_id
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