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Basilar Artery OcclusionPhase 3NCT05827042

Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

A Phase 3 study testing Intravenous thrombolysis and Endovascular thrombectomy 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

To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intravenous thrombolysis and Endovascular thrombectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
1 siteChina
Study dates
9 May 2023to 7 Apr 2026
Phase
Phase 3
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

  • Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
  • Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;
  • Patient's age ≥ 18 years;
  • Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
  • Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;
  • The patient or patient's legal representative signs the informed consent form.

Who cannot join

  • CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds is allowed);
  • Pre-stroke modified Rankin scale (mRS) score ≥ 2;
  • Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) <5;
  • Pregnant or lactating women;
  • Allergy to contrast agent or nitinol alloy;
  • Life expectancy<1 year;
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  • CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment;
  • Participating in other clinical trials;
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, which can not be controlled by antihypertensive drugs;
  • Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) > 1.7; or novel oral anticoagulant within prior 48 hours;
  • Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L), platelet< 100*109/L;
  • Renal insufficiency defined as serum creatinine >2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate <30 mL/min, need for hemodialysis or peritoneal dialysis;
  • Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
  • The patient has acute ischemic cerebral infarction within 3 months from randomization;
  • The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
  • The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;
  • CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
  • Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
  • CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
  • Patients with intracranial tumors (except small meningiomas);
  • Patients who received intravenous thrombolytics treatment before the randomization.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hefei, Anhui, 230001

Other trials in China

About this study

Official title: Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Endovascular Thrombectomy on Acute Basilar Artery Occlusion - a Multicenter, Randomized Controlled, Clinical Trial

To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.

Read the detailed description

Two recent randomized, controlled trials from China-ATTENTION (Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion) and BAOCHE (Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The DEVT (Direct Endovascular Treatment versus Standard Bridging Therapy for Acute Stroke Patients with Large Vessel Occlusion in The Anterior Circulation) and DIRECT-MT (Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Trial) trials showed that endovascular thrombectomy alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. However, it is unclear whether endovascular thrombectomy alone is noninferior to intravenous thrombolysis bridging with endovascular thrombectomy for achieving functional independence at 90 days among patients with acute basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of endovascular thrombectomy alone in these patients.

Being tested
Intravenous thrombolysis, Endovascular thrombectomy
Keywords
Thrombectomy, thrombolysis
Medical subject headings
Stroke

What participants receive

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

  • Intravenous thrombolysisDrug

    Also called Alteplase or Tenecteplase

    Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

  • Endovascular thrombectomyProcedure or surgery

    Endovascular thrombectomy

Study groups in NCT05827042
Study groupRoleWhat they receive
Endovascular thrombectomy aloneExperimentalPatients will receive endovascular thrombectomy without intravenous thrombolysis.
Receives: Procedure: Endovascular thrombectomy
Intravenous thrombolysis plus endovascular thrombectomyActive comparatorPatients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
Receives: Drug: Intravenous thrombolysis; Procedure: Endovascular thrombectomy

What is being measured

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

  1. Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

Secondary outcomes (12)

  1. Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days)

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

  2. Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days)

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

  3. Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 days)

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

  4. Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days)

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

    Measured: 90 (± 14 days) after procedure

  5. Score on the National Institute of Health Stroke Scale (NIHSS) at 24 hours

    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

  6. Score on the NIHSS at 5-7 days or discharge

    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 or discharge after procedure

  7. Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days)

    The EQ-5D-5L is a questionnaire designed to assess five dimensions of life quality related to mobility, self-care, usual activities, pain or discomfort, and anxiety or depression (range: 0.39 to 1, with a higher score indicating a higher quality of living)

    Measured: 90 (± 14 days) after procedure

  8. level of activities of daily living (Barthel index, BI) at 90 days (±14 days)

    The Barthel Index is an ordinal scale for measuring performance of patients'self-care activities of daily living. Scores range from 0 to 100, with 0 indicating severe disability and 95 or 100 indicating no disability that interferes with daily activities.

    Measured: 90 (± 14 days) after procedure

  9. Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy

    Evaluate effect of intravenous thrombolysis on reperfusion

    Measured: within 5 minutes at angiography

  10. Successful reperfusion on final angiography of thrombectomy

    Evaluate effect of thrombectomy on reperfusion

    Measured: Within 5 minutes at final angiography of thrombectomy

  11. Successful recanalization on CT or MR angiography within 72 hours

    Evaluate vascular patency after treatment

    Measured: Within 72 hours after procedure

  12. Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours

    PC-ASPECTS=10 indicates a normal scan, PC-ASPECTS=0 indicates early ischemic changes or hypoattenuation in all above territories. 1 or 2 points each are subtracted for early ischemic changes or hypoattenuation in: left or right thalamus, cerebellum or posterior cerebral artery territory, respectively (1 point); any part of midbrain or pons (2 points)

    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 posted24 Apr 2023
  2. Study start9 May 2023
  3. Primary completion7 Apr 2026
  4. Study completion7 Apr 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827042
Sponsor's protocol ID
ATTENTION IV
Status last verified
Aug 2026
First submitted
12 Apr 2023
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li R, Nguyen TN, Tao C, Sun J, Xu P, Luo C, Wang L, Liu T, Song J, Jing X, Wang A, Qureshi AI, Abdalkader M, Saver JL, Nogueira RG, Hu W. Endovascular thrombectomy alone versus intravenous thrombolysis plus endovascular thrombectomy on acute basilar artery occlusion (ATTENTION IV): study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Aug 12;16(8):e116898. doi: 10.1136/bmjopen-2026-116898.

    PubMed 42586736

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous thrombolysis and Endovascular thrombectomy 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 7 inclusion and 21 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 12 Aug 2026. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 with modified Rankin Score 0-2 at day 90 (±14 days) (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 NCT05827042, which also lists 1 linked publication.

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 12 Aug 2026.

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Clinical Trial NCT05827042 | AzTrials