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NCT06101667
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Conditions: Acute Ischemic Stroke, Basilar Artery Occlusion
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 224
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tiantan Hospital Beijing Beijing Municipality
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age≥18 years
2. Acute basilar artery occlusion confirmed by CTA, MRA, or DSA
3. Pre-stroke mRS of 0-2
4. NIHSS score ≥ 10 before randomization
5. Time interval from symptom onset (or last known well) to randomization within 24-72 hours
6. Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
7. Time from completion of DWI imaging to randomization is ≤3 hours
8. 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
Source: ClinicalTrials.gov (NCT06101667). StuddyBuddy aggregates publicly available trial information.