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Basilar Artery OcclusionNCT04751708

Endovascular Treatment for Acute Basilar Artery Occlusion

A study testing endovascular treatment and best medical management in people with Basilar Artery Occlusion and Acute Cerebrovascular Accident, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site 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

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
endovascular treatment and best medical management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
1 siteChina
Study dates
21 Feb 2021to 3 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptoms and signs compatible with ischemia in the basilar artery territory；
  • Basilar artery occlusion confirmed by CTA/MRA/DSA；
  • Age of 18 years or older；
  • Time from stroke onset to randomization within 12 hours of estimated time of basilar artery occlusion (defined as the sudden onset of stroke symptoms consistent with acute occlusion of the basilar artery (e.g. not considering any previous minor prodromal symptoms) as adjudicated by two local experienced neurologists). If symptoms of sudden deterioration are not witnessed (e.g. wake-up or unwitnessed strokes) the time that the patient was last known to be without any major neurological deficits (such as moderate or severe weakness, stupor, coma) will be used as the time of stroke onset.
  • Written informed consent;
  • National Institutes of Health Stroke Scale (NIHSS) score ≥10 at the time of neuroimaging Exclusion criteria
Show all 14Show fewer
  • 1. Pre-existing dependency with mRS ≥3 for patients<80 years; premorbid mRS≥1 for patients≥80 years； 2. bilateral mydriasis; 3. Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive; 4. Severe contrast allergy or absolute contraindication to iodinated contrast; 5. Participation in other clinical trials; 6. Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs; 7. Known genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; 8. Blood glucose < 2.7 or >22.2 mmol / L; platelet count < 50×109 / L, or hematocrit < 25%; 9. Life expectancy < 1 year； 10. Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)； 11. Acute ischemic cerebral infarction within 48 hours after major surgery (patients can be enrolled if more than 48 hours); 12. Premorbid cerebrovascular inflammation; 13. Premorbid nervous system disease or mental disorders hindering the assessment of the disease; Imaging exclusion criteria
  • CT/MR shows intracranial hemorrhage (patients with microbleeds on MR can be included if lesion diameter ≤5mm);
  • CTA/MRA/DSA shows the artery is seriously tortuous, variability or dissection, and thrombectomy device cannot reach the target vessel;
  • PC-ASPECTS on CT/CTA-Source Images/MRI-DWI <6 for patients<80 years (<8 for patients ≥80 years);
  • CT or MR shows the cerebellar infarction with obvious space occupying effect and obvious compression of the fourth ventricle;
  • Complete bilateral thalami or bilateral brainstem infarction confirmed by CT/MR;
  • Occlusion of both anterior and posterior circulation confirmed by CTA/MRA/DSA;
  • Intracranial tumors (except small meningiomas).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine

    Hefei, Anhui, 239300

Other trials in China

About this study

Official title: Endovascular Treatment for Acute Basilar Artery Occlusion - a Multicenter Randomized Clinical Trial

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results. Besides, a recently prospective clinical registry with large sample size (BASILAR) showed a significantly beneficial effect of EVT in BAO patients.

Objective: To assess the effect of EVT in addition to best medical management (BMM) compared to BMM alone, in patients with BAO, caused by a CTA/MRA confirmed occlusion of the basilar artery on functional and safety outcome.

Read more

Study design: This is a parallel group, randomized clinical trial of EVT with BMM versus BMM. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow up.

Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA.

Main study parameters/outcomes: The primary effect parameter will be favourable outcome at day 90 defined as a modified Rankin Score (mRS) of 0-3. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Being tested
endovascular treatment, best medical management
Keywords
thrombectomy, best medical management, endovascular treatment, randomized, mechanical thrombectomy
Medical subject headings
Stroke

What participants receive

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

  • endovascular treatmentProcedure or surgery

    For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.

  • best medical managementOther

    best medical management

Study groups in NCT04751708
Study groupRoleWhat they receive
best medical managementActive comparatorUnless contra-indicated patients are treated with a standard full dose of open-label IV rt-PA (0.9mg/kg; 90mg maximum). IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion. For the patients in whom the rtPA is contraindicated, the standard medical treatment follows the current guidelines for the early management of patients with acute ischemic stroke from the American Heart Association/American Stroke Association.
Receives: Other: best medical management
endovascular treatment+ best medical managementExperimentalDevice: endovascular treatment For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
Receives: Procedure: endovascular treatment

What is being measured

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

  1. a modified Rankin Score of 0-3

    Favourable outcome at day 90 (± 14 days)

    Measured: 90 (± 14 days) after procedure

Secondary outcomes (6)

  1. a modified Rankin Score of 0-2

    Excellent outcome

    Measured: 90 (± 14 days) after procedure

  2. Modified Rankin Score

    The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

  3. NIHSS score

    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

    Measured: 24 hours after procedure

  4. NIHSS score

    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

    Measured: 5-7 days after procedure

  5. mortality

    (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%

    Measured: 90 (± 14 days) after procedure

  6. symptomatic intracerebral hemorrhage (ICH)

    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

    Measured: within 72 hours after procedure

Timeline

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

  1. First posted12 Feb 2021
  2. Study start21 Feb 2021
  3. Primary completion3 Jan 2022
  4. Study completion3 Apr 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
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751708
Sponsor's protocol ID
Attention
Status last verified
Sep 2022
First submitted
9 Feb 2021
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Guo Z, Nguyen TN, Liu X, Tao C, Xu P, Zhang C, Liu X, Nogueira RG, Hu W, Xiao G; ATTENTION Investigators. Cause-Specific Endovascular Thrombectomy Time Windows in Basilar Artery Occlusion: ATTENTION Trial Post Hoc Analysis. Stroke. 2026 Oct 22. doi: 10.1161/STROKEAHA.126.055537. Online ahead of print.

    PubMed 42910430

  • Guo Z, Liu X, Yu S, Tao C, Xu P, Zhang C, Hu W, Xiao G; ATTENTION Trial Investigators. Remedial angioplasty or stenting in acute basilar artery occlusion: post hoc analysis of ATTENTION trial. J Neurointerv Surg. 2025 Dec 30:jnis-2025-024443. doi: 10.1136/jnis-2025-024443. Online ahead of print.

    PubMed 41469196

  • Hu W, Nguyen TN, Qureshi M, Chen Z, Tao C, Li R, Yi TY, Feng G, Su J, Cui T, Cao Z, Wang H, Zeng G, Yuan G, Jing X, Luo C, Zhu Y, Qureshi AI, Nogueira RG, Liu X, Abdalkader M. Noncontrast CT vs CT Perfusion Imaging in Patients With Basilar Artery Occlusion: Analysis of the ATTENTION and ATTENTION IA Trials. Neurology. 2025 Aug 12;105(3):e213911. doi: 10.1212/WNL.0000000000213911. Epub 2025 Jul 17.

    PubMed 40674670

  • Luo C, Li R, Tao C, Cai M, Chen L, Hao P, Liu X, Hu W; ATTENTION Investigators. The Basilar Artery Collateral Simplified Score: a Novel Collateral Circulation Score Associated With Outcomes in Patients With Basilar Artery Occlusion: Results From the ATTENTION Study. J Am Heart Assoc. 2025 Mar 18;14(6):e038271. doi: 10.1161/JAHA.124.038271. Epub 2025 Mar 13.

    PubMed 40079327

  • Yuan G, Nguyen TN, Liu L, Li R, Xia H, Long C, Wu J, Xu J, Huang F, He B, Wu D, Wang H, Feng C, Liang Y, Zhou X, Xiao Z, Luo L, Hu Y, Liu B, Peng W, Zhang C, Cui T, Zhao G, Xu L, Ma G, Hu W; ATTENTION Investigators. Effect of Stroke Etiology on Endovascular Treatment for Acute Basilar-Artery Occlusion: A Post Hoc Analysis of the ATTENTION Randomized Trial. Stroke. 2024 Aug;55(8):1973-1981. doi: 10.1161/STROKEAHA.124.047568. Epub 2024 Jul 22.

    PubMed 39038096

  • Su J, Hu X, Chen L, Li R, Tao C, Yin Y, Liu H, Tan X, Hou S, Xie S, Huo L, Zhu Y, Gong D, Hu W; ATTENTION investigators-Study Leadership and Committees; ATTENTION investigators - Study Leadership and Committees. Predictors of good outcomes and mortality after thrombectomy for basilar artery occlusion within 12 hours of onset. J Neurointerv Surg. 2024 Dec 26;17(e1):e139-e145. doi: 10.1136/jnis-2023-021057.

    PubMed 38228387

  • Yi T, Li K, Lin XH, Lin DL, Wu YM, Pan ZN, Zheng XF, Chen RC, Zeng G, Chen WH. Predictors of futile recanalization in basilar artery occlusion patients undergoing endovascular treatment: a post hoc analysis of the ATTENTION trial. Front Neurol. 2023 Dec 18;14:1308036. doi: 10.3389/fneur.2023.1308036. eCollection 2023.

    PubMed 38178887

  • Tao C, Nogueira RG, Zhu Y, Sun J, Han H, Yuan G, Wen C, Zhou P, Chen W, Zeng G, Li Y, Ma Z, Yu C, Su J, Zhou Z, Chen Z, Liao G, Sun Y, Ren Y, Zhang H, Chen J, Yue X, Xiao G, Wang L, Liu R, Liu W, Liu Y, Wang L, Zhang C, Liu T, Song J, Li R, Xu P, Yin Y, Wang G, Baxter B, Qureshi AI, Liu X, Hu W; ATTENTION Investigators. Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1361-1372. doi: 10.1056/NEJMoa2206317.

    PubMed 36239644

  • 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.

    PubMed 35858168

  • Tao C, Li R, Zhu Y, Qun S, Xu P, Wang L, Zhang C, Liu T, Song J, Sun W, Wang G, Baxter B, Qureshi A, Liu X, Nogueira RG, Hu W. Endovascular treatment for acute basilar artery occlusion: A multicenter randomized controlled trial (ATTENTION). Int J Stroke. 2022 Aug;17(7):815-819. doi: 10.1177/17474930221077164. Epub 2022 Feb 22.

    PubMed 35102797

Questions about this trial

What is this clinical trial studying?

A study testing endovascular treatment and best medical management in people with Basilar Artery Occlusion and Acute Cerebrovascular Accident, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site 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 14 inclusion and 0 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

a modified Rankin Score of 0-3 (time frame: 90 (± 14 days) after procedure). 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 NCT04751708, which also lists 10 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 15 Sep 2022.

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