Basilar Artery Occlusion Chinese Endovascular Trial

NCT02737189 | Completed DMC

• 1 other identifier: Xuanwu201601
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 36

Brief Summary

Endovascular treatment of acute ischemic stroke has shown strong benefit in several prospective randomized trials in the anterior circulation and endovascular therapy for basilar artery occlusion has shown promising results in several single-arm studies. This has led to a broad adoption of these techniques which are now considered standard of care in many institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates of symptomatic intracerebral hemorrhage in these studies have consistently been around 5% which raises the question as to whether patients could actually be harmed as opposed to helped by these procedures. This is a prospective, multi-center, randomized, controlled, open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.

Conditions

Basilar Artery Occlusion; Ischemic Stroke; Cerebrovascular Disorders

Keywords

Basilar Artery Occlusion; Ischemic Stroke; Mechanical Embolectomy

Outcome Measures

Primary Outcomes (1)

• proportion of patients achieving favourable outcomes defined as mRS 0-3 at 90 days

  The primary objective of this study is to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving favourable outcomes (mRS ≤ 3) at 90 days in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.

  90 days

Secondary Outcomes (15)

• Dramatic early favorable response

  24 (-2/+12) hours

• Dichotomized mRS score (0-2 versus 3-6 and 0-4 versus 5-6 )

  90 days

• Proportion of patients achieving meaningful outcomes defined as mRS 0-4 at 12 months.

  12 months

• Final infarct volume and the change of infarct volume compared with baseline

  24 hours (-2/+12 hours)

• Vessel recanalization with Arterial Occlusive Lesion (AOL) grades

  24 hours (-2/+12 hours)

Study Arms (2)

Endovascular Arm

EXPERIMENTAL

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration Best Medical Treatment and maximum supportive care

Procedure: Mechanical embolectomy; Drug: Medical Treatment

Control Arm

OTHER

Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment

Drug: Medical Treatment

Interventions

Mechanical embolectomy PROCEDURE

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

Endovascular Arm

Medical Treatment DRUG

Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment

Control Arm; Endovascular Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Posterior circulation AIS within 6-24 hours from symptom onset/last seen well where patient is ineligible for i.v. thrombolytic treatment, or patient has received i.v. thrombolytic therapy without recanalization.
• 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.
• Age ≥18 and ≤80 years.
• Baseline National Institutes of Health Stroke Scale (NIHSS) score obtained prior to randomization must be equal to or higher than 6 points.
• No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
• Patient treatable within 24 hours from time last seen well. Isolated vertigo with nausea and/or vomiting is not considered onset of symptom.
• Informed consent obtained from patient or acceptable patient surrogate.

You may not qualify if:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio \> 3.0.
• Baseline platelet count \< 50.000/µL.
• Baseline blood glucose \< 50mg/dL or \> 400mg/dL.
• Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg).
• 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.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life threatening allergy (more than rash) to contrast medium
• Subjects who has received i.v. tissue plasminogen activator (t-PA) treatment beyond 4.5 hours from the beginning of the symptoms.
• 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).
• Renal insufficiency with creatinine ≥ 3 mg/dl.
• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Cerebral vasculitis.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations; mRS score at baseline must be ≤ 1.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• The First People's Hospital of Changzhou: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• Changhai Hospital: collaborator
• Baotou Central Hospital: collaborator
• 904th Hospital of the Joint Logistics Support Force of the PLA: collaborator
• Linyi People's Hospital: collaborator
• The 985 Hospital of PLA, Taiyuan, Shanxi: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Tianjin TEDA Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Subei People's Hospital of Jiangsu Province: collaborator
• PLA 148 Hospital, Zibo, Shandong: collaborator
• Hebei General Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Shenzhen Bao'an District People's Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Henan Provincial People's Hospital: collaborator
• Peking University Binhai Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• The Military General Hospital of Beijing, PLA: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Beijing Luhe Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Nanning Second People's Hospital: collaborator
• Chongqing Three Gorges Central Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Fifth Central Hospital of Tianjin，TianJin: collaborator
• Yantaishan Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Tianjin Huanhu Hospital: collaborator
• The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital: collaborator

Study Sites (36)

Baotou Central Hospital

Baotou, China

Location

Beijing Luhe Hospital

Beijing, China

Location

Beijing Tiantan Hospital

Beijing, China

Location

The Military General Hospital of Beijing, PLA

Beijing, China

Location

Xuanwu Hospital

Beijing, China

Location

The First People's Hospital of Changzhou

Changzhou, China

Location

Chongqing Three Gorges Central Hospital

Chongqing, China

Location

Xinqiao Hospital of Chongqing

Chongqing, China

Location

Shengli Oilfield Hospital

Dongying, China

Location

The Affiliated Hospital Of Guizhou Medical University

Guiyang, China

Location

First Hospital of Jilin University

Jilin, China

Location

Liaocheng Third People's Hospital

Liaocheng, China

Location

Linyi People's Hospital

Linyi, China

Location

Luoyang Central Hospital

Luoyang, China

Location

Nanjing First People's Hospital

Nanjing, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

Location

Nanning Second People's Hospital

Nanning, China

Location

Nantong University

Nantong, China

Location

Nanyang Central Hospital

Nanyang, China

Location

Changhai Hospital

Shanghai, China

Location

Shenzhen Bao'an District People's Hospital

Shenzhen, China

Location

Hebei General Hospital

Shijiazhuang, China

Location

Second Affiliated Hospital of Soochow University

Suzhou, China

Location

PLA 264 Hospital

Taiyuan, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, China

Location

Peking University Binhai Hospital

Tianjin, China

Location

The Fifth Central Hospital of Tianjin

Tianjin, China

Location

Tianjin Huanhu Hospital

Tianjin, China

Location

Tianjin TEDA Hospital

Tianjin, China

Location

The 101st Hospital of Chinese People's Liberation Army

Wuxi, China

Location

The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital

Xi'an, China

Location

Subei People's Hospital of Jiangsu Province

Yangzhou, China

Location

Yantaishan Hospital

Yantai, China

Location

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, China

Location

Henan Provincial Hospital

Zhengzhou, China

Location

PLA 148 Hospital

Zibo, China

Location

Related Publications (24)

• Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.

  PMID: 24449944 BACKGROUND

• Zhou M, Wang H, Zhu J, Chen W, Wang L, Liu S, Li Y, Wang L, Liu Y, Yin P, Liu J, Yu S, Tan F, Barber RM, Coates MM, Dicker D, Fraser M, Gonzalez-Medina D, Hamavid H, Hao Y, Hu G, Jiang G, Kan H, Lopez AD, Phillips MR, She J, Vos T, Wan X, Xu G, Yan LL, Yu C, Zhao Y, Zheng Y, Zou X, Naghavi M, Wang Y, Murray CJ, Yang G, Liang X. Cause-specific mortality for 240 causes in China during 1990-2013: a systematic subnational analysis for the Global Burden of Disease Study 2013. Lancet. 2016 Jan 16;387(10015):251-72. doi: 10.1016/S0140-6736(15)00551-6. Epub 2015 Oct 26.

  PMID: 26510778 BACKGROUND

• Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, Vos T, Wang H, Lopez AD, Murray CJ. Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Jun 8;381(9882):1987-2015. doi: 10.1016/S0140-6736(13)61097-1.

  PMID: 23746901 BACKGROUND

• Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.

  PMID: 22052510 BACKGROUND

• Lindsberg PJ, Pekkola J, Strbian D, Sairanen T, Mattle HP, Schroth G. Time window for recanalization in basilar artery occlusion: Speculative synthesis. Neurology. 2015 Nov 17;85(20):1806-15. doi: 10.1212/WNL.0000000000002129.

  PMID: 26574535 BACKGROUND

• Palaniswami M, Yan B. Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice. Interv Neurol. 2015 Oct;4(1-2):18-29. doi: 10.1159/000438774. Epub 2015 Sep 18.

  PMID: 26600793 BACKGROUND

• Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.

  PMID: 26123479 BACKGROUND

• Chen CJ, Ding D, Starke RM, Mehndiratta P, Crowley RW, Liu KC, Southerland AM, Worrall BB. Endovascular vs medical management of acute ischemic stroke. Neurology. 2015 Dec 1;85(22):1980-90. doi: 10.1212/WNL.0000000000002176. Epub 2015 Nov 4.

  PMID: 26537058 BACKGROUND

• Macleod MR, Davis SM, Mitchell PJ, Gerraty RP, Fitt G, Hankey GJ, Stewart-Wynne EG, Rosen D, McNeil JJ, Bladin CF, Chambers BR, Herkes GK, Young D, Donnan GA. Results of a multicentre, randomised controlled trial of intra-arterial urokinase in the treatment of acute posterior circulation ischaemic stroke. Cerebrovasc Dis. 2005;20(1):12-7. doi: 10.1159/000086121. Epub 2005 May 30.

  PMID: 15925877 BACKGROUND

• Yeung JT, Matouk CC, Bulsara KR, Sheth KN. Endovascular revascularization for basilar artery occlusion. Interv Neurol. 2015 Jan;3(1):31-40. doi: 10.1159/000368968.

  PMID: 25999990 BACKGROUND

• Punal-Rioboo J, Atienza G, Blanco M. Safety and Efficacy of Mechanical Thrombectomy Using Stent Retrievers in the Endovascular Treatment of Acute Ischaemic Stroke: A Systematic Review. Interv Neurol. 2015 Jul;3(3-4):149-64. doi: 10.1159/000430474.

  PMID: 26279662 BACKGROUND

• Akins PT, Amar AP, Pakbaz RS, Fields JD; SWIFT Investigators. Complications of endovascular treatment for acute stroke in the SWIFT trial with solitaire and Merci devices. AJNR Am J Neuroradiol. 2014 Mar;35(3):524-8. doi: 10.3174/ajnr.A3707. Epub 2013 Sep 12.

  PMID: 24029392 BACKGROUND

• Hann S, Chalouhi N, Starke R, Gandhe A, Koltz M, Theofanis T, Jabbour P, Gonzalez LF, Rosenwasser R, Tjoumakaris S. Comparison of neurologic and radiographic outcomes with Solitaire versus Merci/Penumbra systems for acute stroke intervention. Biomed Res Int. 2013;2013:715170. doi: 10.1155/2013/715170. Epub 2013 Dec 30.

  PMID: 24490169 BACKGROUND

• von Kummer R, Broderick JP, Campbell BC, Demchuk A, Goyal M, Hill MD, Treurniet KM, Majoie CB, Marquering HA, Mazya MV, San Roman L, Saver JL, Strbian D, Whiteley W, Hacke W. The Heidelberg Bleeding Classification: Classification of Bleeding Events After Ischemic Stroke and Reperfusion Therapy. Stroke. 2015 Oct;46(10):2981-6. doi: 10.1161/STROKEAHA.115.010049. Epub 2015 Sep 1. No abstract available.

  PMID: 26330447 BACKGROUND

• Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.

  PMID: 17258667 BACKGROUND

• Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998 Oct 17;352(9136):1245-51. doi: 10.1016/s0140-6736(98)08020-9.

  PMID: 9788453 BACKGROUND

• Puetz V, Sylaja PN, Coutts SB, Hill MD, Dzialowski I, Mueller P, Becker U, Urban G, O'Reilly C, Barber PA, Sharma P, Goyal M, Gahn G, von Kummer R, Demchuk AM. Extent of hypoattenuation on CT angiography source images predicts functional outcome in patients with basilar artery occlusion. Stroke. 2008 Sep;39(9):2485-90. doi: 10.1161/STROKEAHA.107.511162. Epub 2008 Jul 10.

  PMID: 18617663 BACKGROUND

• Tomsick T, Broderick J, Carrozella J, Khatri P, Hill M, Palesch Y, Khoury J; Interventional Management of Stroke II Investigators. Revascularization results in the Interventional Management of Stroke II trial. AJNR Am J Neuroradiol. 2008 Mar;29(3):582-7. doi: 10.3174/ajnr.A0843.

  PMID: 18337393 BACKGROUND

• 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.

  PMID: 12869717 BACKGROUND

• 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.

  PMID: 31831388 BACKGROUND

• 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.

  PMID: 32080711 BACKGROUND

• 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.

  PMID: 36239645 DERIVED

• 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.

  PMID: 35858168 DERIVED

• 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.

  PMID: 34427475 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Tudor G Jovin, MD

  University of Pittsburg Medical Center Stroke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: April 13, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 26, 2024

Record last verified: 2022-05

Locations

CN (36)