Acute Ischemic Stroke Clinical Trial
— ANGEL-BAOOfficial title:
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial(ANGEL-BAO)
The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.
Status | Recruiting |
Enrollment | 224 |
Est. completion date | December 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age=18 years 2. Pre-stroke mRS of 0-2 3. NIHSS score = 10 before randomization 4. Time interval from symptom onset (or last known well) to randomization within 24-72 hours 5. Diffusion-weighted imaging(DWI)-based pc-ASPECTS = 6 and Pons-Midbrain Index (PMI) =3 6. Time from completion of DWI imaging to randomization is =3 hours 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. CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm < 3mm in diameter) 4. Known or highly suspected chronic occlusion of basilar artery 5. History of contraindication for contrast medium (except mild rash) 6. Current pregnant or breast-feeding 7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up 8. Life expectancy is less than 3 months 9. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months. 10. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 18-36 hours after randomization | |
Other | Rate of any 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 | |
Other | All cause of mortality within 7 (±3) days after randomization | All cause of mortality within 7 (±3) days after randomization | 7 (±3) days after randomization | |
Other | All cause of mortality within 90 (±14) days after randomization | All cause of mortality within 90 (±14) days after randomization | 90±14 days after randomization | |
Primary | 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. | 90±14 days after randomization | |
Secondary | Rate of 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. | 90±14 days after randomization | |
Secondary | 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. | 90±14 days after randomization | |
Secondary | Rate of 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. | 24 hours after randomization | |
Secondary | Rate of NIHSS score at 7 (±3) 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. | 7 (±3) days after randomization or at discharge | |
Secondary | Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 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. | 90±14 days after randomization | |
Secondary | Proportion of basilar artery recanalization at 18-36 hours after randomization | Basilar artery recanalization is defined as grade 2-3 of arterial occlusive lesion (AOL) scale.
The AOL Score was defined as: 0=no recanalization of the primary occlusion, I=incomplete or partial recanalization of the primary occlusion with no distal flow, II=incomplete or partial recanalization of the primary occlusion with distal flow, or III=complete recanalization of the primary occlusion with distal flow. |
18-36 hours after randomization |
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