Phase
Condition
Stroke
Cerebral Ischemia
Treatment
Endovascular thrombectomy
Tenecteplase
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients presenting with posterior circulation ischemic stroke symptoms due tobasilar artery occlusion or vertebral artery occlusions that prevent antegrade flowinto the basilar artery;
Time from stroke onset to randomization within 4.5-24 hours of estimated time ofbasilar artery occlusion;
Patient's age≥18 years;
Presence of basilar artery or vertebral artery occlusion, confirmed by CTAngiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). Incases of vertebral artery occlusion, the occlusion must completely prevent antegradeflow into the basilar artery;
Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenousthrombolysis;
Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time ofneuroimaging;
The patient or patient's legal representative signs the informed consent form.
Exclusion
Exclusion Criteria:
CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds isallowed);
Pre-stroke modified Rankin scale (mRS) score of ≥ 2;
Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/CTA-Source Images<6; PC-ASPECTS on magnetic resonance imaging-diffusion weightedimaging (MRI-DWI) <5;
Pregnant or lactating women;
Allergy to contrast agent or nitinol alloy;
Life expectancy<1 year;
CTA/MRA/DSA show vascular tortuosity, vascular variation or artery dissection, whichwould make it difficult to perform endovascular treatment;
Participating in other clinical trials;
Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, whichcannot be controlled by antihypertensive drugs;
Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; or oralanticoagulant with international normalized ratio (INR) > 1.7, or novel oralanticoagulant within prior 48 hours;
Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L), platelet< 100*109/L;
Renal insufficiency defined as serum creatinine >2.0 mg/dl (or 176.8 μ mol/l) or aglomerular filtration rate <30 mL/min or the need for hemodialysis or peritonealdialysis;
Patients who cannot complete 90-day follow-up (such as patients without fixedresidence, overseas patients, etc);
The patient has acute ischemic cerebral infarction within 3 months fromrandomization;
The patient had a history of or clinical suspicion for cerebral vasculitis orinfectious endocarditis;
The patient has nervous system disease or mental disorder before stroke onset, whichmay affect the assessment of their condition;
CT or MR examination showed large cerebellar infarction with obvious space occupyingeffect and compression of the fourth ventricle;
Patients with extensive bilateral thalamic or extensive bilateral brainsteminfarction on CT or MR examination;
CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
Patients with intracranial tumors (except small meningiomas);
Patients who received intravenous thrombolytics treatment before the randomization;
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui 230001
ChinaActive - Recruiting
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