An interventional study of Endovascular Therapy Plus Best Medical Treatment and Best Medical Treatment Alone in Basilar Artery Occlusion, Ischemic Stroke and Large Core Infarct, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 314 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical exclusion criteria:
Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
Neuroimaging exclusion criteria:
Patients randomized to this arm will receive endovascular therapy (EVT) in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours.The EVT strategy will be selected by the treating neurointerventionalist based on vascular findings. Allowed procedures include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or a combination of these.
Procedure: Endovascular Therapy Plus Best Medical Treatment
Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed.
Drug: Best Medical Treatment Alone
Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.
Also known as: Mechanical Thrombectomy
Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.
Proportion of Patients Achieving mRS 0-3 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome.
Time frame: 90 days
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.
Time frame: 24 (-2/+12) hours
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Proportion of Patients Achieving mRS 0-4 at 90 Days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Barthel Index
The Barthel Index ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better outcomes.
Time frame: 90 days
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 6 months
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 12 months
Proportion of basilar artery recanalization
Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades
Time frame: 24 hours (-2/+12 hours)
Mortality
Time frame: 90 days
Symptomatic intracranial hemorrhage
Time frame: 24 (-2/+12) hours
Serious adverse events
All serious adverse events during follow-up in all randomized patients.
Time frame: 90 days, 12 months, through study completion ( average of 1 year)
Plan to share: No — The study is proceeding.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Capital Medical University