Acute Basilar Artery Occlusion, Endovascular Therapy, Large Core Infarction
Conditions
Keywords
Ischemic Stroke, Acute Basilar Artery Occlusion, Endovascular Therapy, Large Core Infarction
Brief summary
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
Detailed description
This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)
Interventions
PROCEDUREEndovascular Recanalization Strategy
The 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 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The age ranged from 18 to 80 years 2. Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours 3. Acute basilar artery occlusion confirmed by CTA,MRA,or DSA 4. Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3 5. NIHSS score ≥10 before randomization 6. Pre-stroke mRS of 0-2 7. Each patient or their legal representative must provide written informed consent before enrolment
Exclusion criteria
1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization 2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging 3. Known or highly suspected chronic occlusion of basilar artery 4. History of contraindication for contrast medium (except mild rash) 5. Current pregnant or breast-feeding 6. Refractory hypertension (defined as systolic blood pressure\>220 mmHg or diastolic blood pressure\>110 mmHg) that cannot be controlled by drug treatment; 7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up 8. It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up 9. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.) 10. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months 11. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study 12. CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation 13. Central nervous system vasculitis has been diagnosed or clinically suspected 14. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR\>1.7 15. Blood glucose\<2.7 or\>22.2 mmol/L; Platelet count\<50×109/L, glomerular filtration rate\<30ml/min or serum creatinine ≥ 3 mg/dl 16. Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS score at 7 days after randomization or discharge (whichever came first) | 7 days after randomization or at discharge | The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
| The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization | 90±14 days after randomization | The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization. |
| Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD) | 18-36 hours after randomization | Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD). |
| Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3) | At the end of the operation | Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3). |
| The proportion of mRS 0-4 at 90 (± 14) days after randomization | 90±14 days after randomization | The proportion of mRS 0-4 at 90 (± 14) days after randomization. |
| MRS score as an ordinal scale at 90 (±14) days after randomization | 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. |
| Rate of mRS 0-2 at 90 (±14) days after randomization | 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. |
| National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization | 24 hours after randomization | The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
| Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization | 90±14 days after randomization | EuroQol Five Dimensions (EQ-5D) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All cause of mortality within 7 days after randomization | 7 days after randomization | All cause of mortality within 7 days after randomization |
| All cause of mortality within 90 (±14) days after randomization | 90±14 days after randomization | All cause of mortality within 90 (±14) days after randomization |
| 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 | Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours. |
| Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 18-36 hours of randomization | 18-36 hours after 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. |
Countries
China
Contacts
Primary ContactFeng Gao, MD
Outcome results
None listed