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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| best medical management | Active Comparator | Unless 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. |
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| endovascular treatment+ best medical management | Experimental | Device: 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| a modified Rankin Score of 0-3 | Favourable outcome at day 90 (± 14 days) | 90 (± 14 days) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| a modified Rankin Score of 0-2 | Excellent outcome | 90 (± 14 days) after procedure |
| Modified Rankin Score | The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability. |
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Inclusion Criteria
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine | Hefei | Anhui | 239300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41469196 | Derived | 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. | |
| 40674670 | Derived |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| best medical management | Other | best medical management |
|
| 90 (± 14 days) after procedure |
| 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. | 24 hours after procedure |
| 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. | 5-7 days after procedure |
| mortality | (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% | 90 (± 14 days) after procedure |
| 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. | within 72 hours after procedure |
| 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. |
| 40079327 | Derived | 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. |
| 39038096 | Derived | 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. |
| 38228387 | Derived | 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. |
| 38178887 | Derived | 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. |
| 36239644 | Derived | 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. |
| 35858168 | 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. |
| 35102797 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |