Basilar Artery Occlusion, Ischemic Stroke, Large Core Infarct
Conditions
Keywords
Endovascular Therapy, Large Core Infarct, Randomized Controlled Trial
Brief summary
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
Detailed description
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.
Interventions
PROCEDUREEndovascular Therapy Plus Best Medical Treatment
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.
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.
Sponsors
Capital Medical University
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. Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well. 2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA. 3. Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT. 4. Age ≥18 and ≤80 years. 5. Baseline NIHSS score ≥6 at the time of randomization. 6. No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1). 7. Informed consent obtained from patient or acceptable patient surrogate.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving mRS 0-3 at 90 Days | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving mRS 0-4 at 90 Days | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months | 6 months | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months | 12 months | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Proportion of basilar artery recanalization | 24 hours (-2/+12 hours) | Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades |
| Dramatic early favorable response | 24 (-2/+12) hours | 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. |
| Ordinal Shift analysis of mRS at 90 days | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Dichotomized mRS score (0-2 versus 3-6 ) | 90 days | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]) |
| Barthel Index | 90 days | The Barthel Index ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | 90 days, 12 months, through study completion ( average of 1 year) | All serious adverse events during follow-up in all randomized patients. |
| Symptomatic intracranial hemorrhage | 24 (-2/+12) hours | — |
| Mortality | 90 days | — |
Countries
China
Contacts
Primary ContactXunming Ji
Backup ContactChuanhui Li
Outcome results
None listed