AzTrials
AzTrials

Basilar Artery OcclusionNCT02737189

Basilar Artery Occlusion Chinese Endovascular Trial

A study testing Mechanical embolectomy and Medical Treatment in people with Basilar Artery Occlusion and Ischemic Stroke, run by Xuanwu Hospital, Beijing at 36 sites in China.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Mechanical embolectomy and Medical Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
36 sitesChina
Study dates
Jul 2016to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • General Exclusion Criteria:
  • 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.
Show all 25Show fewer
  • 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.
  • Unlikely to be available for 90 days follow-up.
  • Neuroimaging Exclusion Criteria:
  • 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.
  • CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
  • Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
  • Complete unilateral or bilateral thalamic infarction on CT or MRI
  • 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.
  • Subjects with occlusions in both anterior and posterior circulation.
  • Evidence of intracranial tumor (except small meningioma).

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

China36 sites

  • Baotou Central Hospital

    Baotou

  • Beijing Luhe Hospital

    Beijing

  • Beijing Tiantan Hospital

    Beijing

  • The Military General Hospital of Beijing, PLA

    Beijing

  • Xuanwu Hospital

    Beijing

  • The First People's Hospital of Changzhou

    Changzhou

  • Chongqing Three Gorges Central Hospital

    Chongqing

  • Xinqiao Hospital of Chongqing

    Chongqing

  • Shengli Oilfield Hospital

    Dongying

  • The Affiliated Hospital Of Guizhou Medical University

    Guiyang

  • First Hospital of Jilin University

    Jilin City

  • Liaocheng Third People's Hospital

    Liaocheng

  • Linyi People's Hospital

    Linyi

  • Luoyang Central Hospital

    Luoyang

  • Nanjing First People's Hospital

    Nanjing

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing

  • Nanning Second People's Hospital

    Nanning

  • Nantong University

    Nantong

  • Nanyang Central Hospital

    Nanyang

  • Changhai Hospital

    Shanghai

  • Shenzhen Bao'an District People's Hospital

    Shenzhen

  • Hebei General Hospital

    Shijiazhuang

  • Second Affiliated Hospital of Soochow University

    Suzhou

  • PLA 264 Hospital

    Taiyuan

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan

  • Peking University Binhai Hospital

    Tianjin

  • The Fifth Central Hospital of Tianjin

    Tianjin

  • Tianjin Huanhu Hospital

    Tianjin

  • Tianjin TEDA Hospital

    Tianjin

  • The 101st Hospital of Chinese People's Liberation Army

    Wuxi

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

    Xi'an

  • Subei People's Hospital of Jiangsu Province

    Yangzhou

  • Yantaishan Hospital

    Yantai

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou

  • Henan Provincial Hospital

    Zhengzhou

  • PLA 148 Hospital

    Zibo

Other trials in China

About this study

Official title: Randomized Trial of Revascularization With Solitaire Stentriever Versus Best Medical Therapy in the Treatment of Acute Ischemic Stroke Due to Basilar Artery Occlusion Presenting Within 6-24 Hours of Symptom Onset

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.

Read the detailed description

Study Objective: To evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving favourable outcomes defined as modified Rankin score (mRS) 0-3 at 90 days in subjects presenting with ischemic stroke due to basilar artery occlusion up to 24 hours from symptom onset.

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.

Being tested
Mechanical embolectomy, Medical Treatment
Keywords
Basilar Artery Occlusion, Ischemic Stroke, Mechanical Embolectomy
Medical subject headings
Ischemic Stroke, Cerebrovascular Disorders

What participants receive

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

  • Mechanical embolectomyProcedure or surgery

    Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

  • Medical TreatmentDrug

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

Study groups in NCT02737189
Study groupRoleWhat they receive
Endovascular ArmExperimentalMechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration Best Medical Treatment and maximum supportive care
Receives: Procedure: Mechanical embolectomy; Drug: Medical Treatment
Control ArmOtherBest Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Receives: Drug: Medical Treatment

What is being measured

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

  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.

    Measured: 90 days

Secondary outcomes (15)

  1. Dramatic early favorable response

    Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.

    Measured: 24 (-2/+12) hours

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

    Measured: 90 days

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

    Measured: 12 months

  4. Final infarct volume and the change of infarct volume compared with baseline

    Infarct volume evaluated on Computed Tomography (CT) or Magnetic Resonance (MR) at 24 hours (-2/+12 hours)

    Measured: 24 hours (-2/+12 hours)

  5. Vessel recanalization with Arterial Occlusive Lesion (AOL) grades

    Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades

    Measured: 24 hours (-2/+12 hours)

  6. Modified Rankin Score (mRS)

    Measured: 90 days

  7. Barthel Index

    Measured: 90 days

  8. NIHSS

    Measured: 90 days

  9. Quality of life analysis

    Quality of life analysis as measured by EuroQol/EQ5D and SF-36 at 3 month, 6 months and 1 year, between interventional therapy vs medical therapy alone

    Measured: 3 month, 6 months and 1 year

  10. Mortality

    Measured: at 90 days

  11. Symptomatic intracranial hemorrhage （SICH）

    Measured: 24 (-2/+12) hours

  12. Serious Adverse Events

    Measured: 1 year

  13. Montreal Cognition Test (MOCA)

    Measured: 90 days

  14. Immediate Post-Endovascular Treatment Recanalization (for the Solitaire arm only)

    Successful recanalization is defined as TICI (Thrombolysis in Cerebral Infarction) 2b or 3 in the post-procedure angiography.

    Measured: Immediate Post-Endovascular Treatment

  15. Procedural related complications

    arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on.

    Measured: Perioperative period

Timeline

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

  1. First posted13 Apr 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionSep 2021
  4. Study completionJun 2022

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737189
Sponsor's protocol ID
Xuanwu201601
Status last verified
May 2022
First submitted
6 Mar 2016
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24449944

  • 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.

    PubMed 26510778

  • 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.

    PubMed 23746901

  • 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.

    PubMed 22052510

  • 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.

    PubMed 26574535

  • 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.

    PubMed 26600793

  • 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.

    PubMed 26123479

  • 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.

    PubMed 26537058

  • 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.

    PubMed 15925877

  • 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.

    PubMed 25999990

  • 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.

    PubMed 26279662

  • 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.

    PubMed 24029392

  • 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.

    PubMed 24490169

  • 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.

    PubMed 26330447

  • 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.

    PubMed 17258667

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical embolectomy and Medical Treatment in people with Basilar Artery Occlusion and Ischemic Stroke, run by Xuanwu Hospital, Beijing at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of patients achieving favourable outcomes defined as mRS 0-3 at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737189, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in