Phase
Condition
Stroke
Thrombosis
Cerebral Ischemia
Treatment
Mechanical thrombectomy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years
Present 24-72 hours of stroke onset or last seen well
Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotidartery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment)on brain imaging
National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
Viable cerebral tissue on computerized tomography perfusion (CTP) or magneticresonance imaging perfusion (MRP) assessed: infarct core volume <50mL, mismatchratio ≥1.8 and mismatch volume ≥15mL
Written informed consent (by patient or proxy, according to local requirements)
Exclusion
Exclusion Criteria:
Clinical Exclusion Criteria
Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-strokedisability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death),as judged by the responsible treating clinician
Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
Pregnancy
Unable to undergo a CTP or MRP
Known allergy to iodine, heparin, anaesthesia, or other definite contraindication toreceiving endovascular treatment (EVT) procedure
Seizures at stroke onset or before randomization and baseline NIHSS scores cannot beaccurately determined
Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)
Baseline platelet count <50,000/uL
Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency;recent oral anticoagulant therapy with International normalized ratio (INR) >3
Severe, sustained hypertension (systolic blood pressure (BP) >220 mmHg or diastolicBP >120 mmHg)
Presumed septic embolus, suspicion of bacterial endocarditis
EVT attempted after stroke onset
Unlikely to participate in follow-up assessments
Currently participating in another trial that may affect outcomes.
Any other condition that, in the opinion of the investigator will pose a significanthazard to the subject if participating in the trial.
Neuroimaging Exclusion Criteria
Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricularhemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
Evidence of intracranial tumor (except small meningioma)
Significant mass effect with midline shift
Aortic dissection
Intracranial stent implanted in the same vascular territory
Any other condition that may affect EVT procedure, like the tortuous vascular paththe device is difficult to reach the target position or difficult to recover
Occlusions in multiple vascular territories confirmed on Computerized tomographyangiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCAocclusions, or an MCA and a basilar artery occlusion)
Study Design
Study Description
Connect with a study center
Changhai Hospital
Shanghai,
ChinaActive - Recruiting
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