Stroke Due to Basilar Artery OcclusionBESTNCT02441556

Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

A study testing endovascular treatment and standard medical therapy in people with Stroke Due to Basilar Artery Occlusion and Acute Cerebrovascular Accidents, run by Xinfeng Liu at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke Due to Basilar Artery Occlusion, Acute Cerebrovascular Accidents
What is being tested?: endovascular treatment and standard medical therapy
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 44 sitesChina
Study dates: Jan 2015to 30 Dec 2017
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years;
Acute ischemic stroke consistent with infarction in the basilar artery territory;
Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
Written informed consent from patient or surrogate, if unable to provide consent.

Who cannot join

Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
Premorbid mRS ≥ 3 points;
Currently in pregnant or lactating;
Known serious sensitivity to radiographic contrast agents and nitinol metal;
Current participation in another investigation drug or device study;
Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication;

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Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
Arterial tortuosity that would prevent the device from reaching the target vessel;
Life expectancy less than 1 year;
History of major hemorrhage in the past 6 months;
Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
Angiographic evidence of bilateral extended brainstem ischemia.

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

China44 sites

123rd Hospital of The People's Liberation Army
Bengbu, Anhui, 233010
Changsha Central Hospital
Changsha, Hunan
Chengdu Military General Hospital
Chengdu, Sichuan
Sichuan People's Hospital
Chengdu, Sichuan
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Xinqiao Hospital, the Third Military Medical University
Chongqing
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, 350025
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, 510080
The Chinese Armed Police Force Guangdong Armed Police Corps hospital
Guangzhou, Guangdong, 510507
the First People's Hospital of Hangzhou,Nanjing Medical University
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui, 230001
the First Affiliated Hospital of An'hui Medical University
Hefei, Anhui
the First People's Hospital of Huainan
Huainan, Anhui
Linyi People's Hospital
Linyi, Shandong, 276002
Lishui Central Hospital
Lishui, Zhejiang
Lu'an Affiliated Hospital of Anhui Medical University
Lu'an, Anhui, 237005
Maoming People's Hospital
Maoming, Guangdong
Mianyang Central Hospital
Mianyang, Sichuan
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266005
Qingdao Municipal Hospital
Qingdao, Shandong
Shenzhen Nanshan Hospital
Shenzhen, Guangdong
Taian City Central Hospital
Taian, Shandong, 271099
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Hubei Zhongshan Hospital
Wuhan, Hubei
Wuhan No.1 Hospital
Wuhan, Hubei
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241001
101st hospital of PLA
Wuxi, Jiangsu
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
Xiamen, Fujian
Affiliated Zhongshan Hospital of Xiamen University
Xiamen, Fujian
the Second Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu
the Third People's Hospital of Yancheng
Yancheng, Jiangsu
Yangzhou No.1 People's Hospital
Yangzhou, Jiangsu, 225012
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
the First People's Hospital of Yangzhou， Yangzhou University
Yangzhou, Jiangsu
Yangzhou Hongquan Hospital
Yangzhou, Jiangsu
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Henan Provincial People's Hospital,Zhengzhou University
Zhengzhou, Henan, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052

Other trials in China

About this study

Read the detailed description

This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.

In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.

Conditions: Stroke Due to Basilar Artery Occlusion, Acute Cerebrovascular Accidents
Being tested: endovascular treatment, standard medical therapy
Keywords: thrombectomy, rt-PA, stroke, endovascular treatment, randomized
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

endovascular treatmentDevice
The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
standard medical therapyOther
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.

Study groups in NCT02441556
Study group	Role	What they receive
standard medical therapy	Active comparator	Patients receive standard medical therapy alone. Receives: Other: standard medical therapy
endovascular + standard medical therapy	Experimental	Patients receive endovascular treatment plus standard medical therapy. Receives: Device: endovascular treatment; Other: standard medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

modified Rankin Scale (mRS)
A score of 0-3 will be considered as the favorable outcome.
Measured: at 90 days from randomization

Secondary outcomes (17)

mRS score 0-2
Measured: at 90 days from randomization
Change of mRS score(shift analysis)
Measured: at 90 days from randomization
Vessel recanalization rate evaluated by CT angiography or MRA
Measured: at 24 hours from randomization
PC-ASPECT score on CT/MRI
Measured: at 24 hours from randomization
GCS score
Measured: at 24 hours from randomization
NIHSS score
Measured: at 24 hours from randomization
GCS score
Measured: at 5-7 days from randomization
NIHSS score
Measured: at 5-7 days from randomization
EuroQol 5D (EQ-5D)
Measured: at 90 days from randomization
mortality
Measured: at 3 months from randomization
symptomatic intracerebral hemorrhage (ICH)
Measured: within 24 hours from randomization
incidence of non-intracerebral hemorrhage complications
Measured: at 90 days from randomization
severity of non-intracerebral hemorrhage complications
Measured: within 90 days from randomization
incidence of nonbleeding severe adverse events (SAEs)
Measured: within 90 days from randomization
severity of nonbleeding severe adverse events (SAEs)
Measured: within 90 days from randomization
incidence of procedure and device related complications
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Measured: within 90 days from randomization
severity of procedure and device related complications
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Measured: within 90 days from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201530 Dec 2017

First posted12 May 2015 (estimated)
Study startJan 2015
Primary completion27 Sep 2017
Study completion30 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Stroke Due to Basilar Artery OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02441556
Sponsor's protocol ID: JLH-NEURO-2015-001
Acronym: BEST
Status last verified: Dec 2016
First submitted: 16 Apr 2015
Last updated: 31 Jul 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.
PubMed 19577962
National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
PubMed 7477192
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
PubMed 18815396
Saqqur M, Uchino K, Demchuk AM, Molina CA, Garami Z, Calleja S, Akhtar N, Orouk FO, Salam A, Shuaib A, Alexandrov AV; CLOTBUST Investigators. Site of arterial occlusion identified by transcranial Doppler predicts the response to intravenous thrombolysis for stroke. Stroke. 2007 Mar;38(3):948-54. doi: 10.1161/01.STR.0000257304.21967.ba. Epub 2007 Feb 8.
PubMed 17290031
Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6.
PubMed 23387822
Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7.
PubMed 23390923
Kidwell CS, Jahan R, Gornbein J, Alger JR, Nenov V, Ajani Z, Feng L, Meyer BC, Olson S, Schwamm LH, Yoo AJ, Marshall RS, Meyers PM, Yavagal DR, Wintermark M, Guzy J, Starkman S, Saver JL; MR RESCUE Investigators. A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):914-23. doi: 10.1056/NEJMoa1212793. Epub 2013 Feb 8.
PubMed 23394476
Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators; Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28.
PubMed 18309168
Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.
PubMed 22932714
Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.
PubMed 22932715
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.
PubMed 25517348
Mattle HP, Arnold M, Lindsberg PJ, Schonewille WJ, Schroth G. Basilar artery occlusion. Lancet Neurol. 2011 Nov;10(11):1002-14. doi: 10.1016/S1474-4422(11)70229-0.
PubMed 22014435
Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
PubMed 23370205
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.
PubMed 31831388
Liu X, Xu G, Liu Y, Zhu W, Ma M, Xiong Y, Zi W, Dai Q, Leung T, Yan B, Davis S, Liebeskind DS, Pereira VM, Nogueira RG; BEST Trial Investigators. Acute basilar artery occlusion: Endovascular Interventions versus Standard Medical Treatment (BEST) Trial-Design and protocol for a randomized, controlled, multicenter study. Int J Stroke. 2017 Oct;12(7):779-785. doi: 10.1177/1747493017701153. Epub 2017 Mar 31.
PubMed 28361616