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NCT05827042
Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion
Conditions: Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 338
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Location: The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui
Summary
To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.
Eligibility Criteria
Inclusion Criteria:
1. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
2. Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;
3. Patient's age ≥ 18 years;
4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
5. Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;
6. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;
7. The patient or patient's legal representative signs the informed consent form.
Exclusion Criteria:
1. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
2. Pre-stroke modified Rankin scale (mRS) score ≥ 2;
3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\ 1.7; or novel oral anticoagulant within prior 48 hours;
11. Blood glucose \400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L;
12. Renal insufficiency defined as serum creatinine \>2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate \
Source: ClinicalTrials.gov (NCT05827042). StuddyBuddy aggregates publicly available trial information.