Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial

Recruiting now · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS

Key facts

Study ID

NCT05326932

Run by

Fudan University

People needed

336

Starts

2022-11-03

Expected to finish

2028-03-31

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 carotid artery (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) assessed: infarct core volume <50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
• Written informed consent (by patient or proxy, according to local requirements)

You may not qualify if…

• Clinical Exclusion Criteria
• Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (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
• Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
• Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
• Baseline blood glucose of <50 mg/dL (2.78 mmol/L) or >400 mg/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 that can not be controlled by medication (systolic BP >220 mmHg or diastolic BP >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 significant hazard to the subject if participating in the trial.
• Neuroimaging Exclusion Criteria
• Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
• Evidence of intracranial malignant tumor
• 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 path the device is difficult to reach the target position or difficult to recover
• Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)

Where it is running

• Changhai Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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