Acute Basilar Artery Occlusion, Posterior Circulation Large Infarct
Conditions
Brief summary
The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct.
Detailed description
This study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
Interventions
PROCEDUREEndovascular Thrombectomy (EVT)
A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire AB/FR device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion, angioplasty and subsequent stenting through detachment of the Solitaire device will be allowed
Sponsors
Feng Gao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years old; 2. Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours; 3. CTA/MRA/DSA confirmed acute basilar artery occlusion; 4. Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points; 5. NIHSS score ≥10 points after the onset of the stroke and before enrollment; 6. Able to live independently before the onset of the disease (mRS score ≤2 points); 7. The subject or legal representative is able to sign the informed consent form.
Exclusion criteria
1. Intracranial hemorrhage (except microhemorrhage) on CT/MRI ; 2. CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem; 3. CT or MRI showed bilateral complete thalamic infarction; 4. Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA; 5. The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of \<3mm); 6. Patients with known or highly suspected chronic basilar artery occlusion.; 7. Known severe allergy to contrast agents (except for mild rash); 8. Refractory hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \>110 mmHg) that cannot be controlled by drug therapy; 9. Known pregnant or lactating females, or positive pregnancy test before enrollment; 10. Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of modified Rankin scale 0-3 at 90 (±14) days after enrollment | 90 (±14) days | 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 |
|---|---|---|
| Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment | 90 (±14) days | 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 enrollment | 90 (±14) days | 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 Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment | 90 (±14) days | 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 |
|---|---|---|
| Mortality within 90 (±14) days | 90 (±14) days | all-cause mortality |
| Rate of Symptomatic intracranial hemorrhage (SICH) | 24-72 hours | Symptomatic intracranial hemorrhage (SICH) within 24-72 hours after enrollment |
Countries
China
Outcome results
None listed