Vertebrobasilar Stroke
Conditions
Keywords
endovascular treatment, thrombolysis
Brief summary
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Detailed description
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation. The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Interventions
PROCEDUREEndovascular treatment
Endovascular treatment
OTHERStandard medical treatment
Standard medical treatment
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: i. 18 \ 80 years old, pc-ASPECTS score ≥ 6; ii. \> 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset 2. NIHSS score ≥ 10 before randomization; 3. VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA; 4. Time from stroke onset to randomization within 23.5 hours; 5. Written informed consent is obtained from patients and/or their legal representatives.
Exclusion criteria
1. CT or MR evidence of intracranial hemorrhage; 2. Pre-morbidity with a modified Rankin scale score ≥ 3; 3. The patient is in deep coma; 4. Currently in pregnant or lactating or serum beta HCG test is positive on admission; 5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 6. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys; 7. Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging; 8. Imaging manifestations of diffuse bilateral brainstem ischemia; 9. Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion); 10. Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect; 11. Participating in other clinical trials; 12. Any terminal illness with life expectancy less than 6 months; 13. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 14. Past neurological or psychiatric diseases that hinder the assessment of neurological function; 15. Unlikely to be available for 90-day follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale score | 90 days | disability level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in NIHSS between baseline and 24 hours | at 24 hours from randomization | neurological changes |
| Improvement in NIHSS between baseline and 5~7d | at 5~7 days from randomization | neurological changes |
| Improvement in GCS between baseline and 24 hours | at 24 hours from randomization | neurological changes |
| Asymptomatic intracranial hemorrhage within 48 hours | within 48 hours after endovascular treatment | evaluate intracranial hemorrhage |
| Rate of a score of 0~2 on modified Rankin scale | 90 days | Functional independence |
| Serious non-hemorrhagic adverse events | within 90 days | evaluate complications and any adverse events |
| Score of 90-day EQ-5D scale | 90 days | Functional independence |
| Mortality within 90 days | 90 days | evaluate death rate of the two treatment groups |
| Symptomatic intracranial hemorrhage within 48 hours | within 48 hours after endovascular treatment | evaluate intracranial hemorrhage |
| Procedural-related complications and severe adverse events | within 90 days | evaluate complications and any adverse events |
Countries
China
Outcome results
None listed