Endovascular Treatment for Acute Basilar Artery Occlusion

NCT04751708 | Completed DMC

• 1 other identifier: Attention
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Basilar Artery Occlusion; Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion

Keywords

thrombectomy; best medical management; endovascular treatment; randomized; mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• a modified Rankin Score of 0-3

  Favourable outcome at day 90 (± 14 days)

  90 (± 14 days) after procedure

Secondary Outcomes (6)

• a modified Rankin Score of 0-2

  90 (± 14 days) after procedure

• Modified Rankin Score

  90 (± 14 days) after procedure

• NIHSS score

  24 hours after procedure

• NIHSS score

  5-7 days after procedure

• mortality

  90 (± 14 days) after procedure

Study Arms (2)

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.

Other: best medical management

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.

Procedure: endovascular treatment

Interventions

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.

endovascular treatment+ best medical management

best medical management OTHER

best medical management

best medical management

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

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

Hefei, Anhui, 239300, China

Location

Related Publications (9)

• 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.

  PMID: 41469196 DERIVED

• 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.

  PMID: 40674670 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.

  PMID: 40079327 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.

  PMID: 39038096 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.

  PMID: 38228387 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.

  PMID: 38178887 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.

  PMID: 36239644 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

• 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.

  PMID: 35102797 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: February 21, 2021
• Primary Completion: January 3, 2022
• Study Completion: April 3, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

CN (1)