The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The age ranged from 18 to 80 years
Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
Disqualifiers
Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
Known or highly suspected chronic occlusion of basilar artery
History of contraindication for contrast medium (except mild rash)
Trial design
Design model
Parallel
Treatments tested in this trial
Endovascular Recanalization Strategy
Procedure/SurgeryThe endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Best Medical Management
DrugBest medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy.
Treatment groups
308 Participants
are divided into 2 treatment groupsGroup A: Endovascular Treatment GroupExperimental treatment 1 intervention
Group B: Best Medical Management GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame
90±14 days after randomizationSecondary outcomes
1
MRS score as an ordinal scale at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame
90±14 days after randomization2
Rate of mRS 0-2 at 90 (±14) days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame
90±14 days after randomization3
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame
24 hours after randomization4
NIHSS score at 7 days after randomization or discharge (whichever came first)
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame
7 days after randomization or at dischargeOther outcomes
1
Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 18-36 hours of randomization
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration.
Time frame
18-36 hours after randomization2
Rate of any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours.
Time frame
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours3
All cause of mortality within 7 days after randomization
All cause of mortality within 7 days after randomization
Time frame
7 days after randomization4
All cause of mortality within 90 (±14) days after randomization
All cause of mortality within 90 (±14) days after randomization
Time frame
90±14 days after randomizationSponsors and contacts
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Source ClinicalTrials.gov
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