Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke (NCT06210633) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke
China1,000 participantsStarted 2024-01-20
Plain-language summary
Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years;
✓. Presenting with acute ischemic stroke within 24 hours of time from last known well;
✓. The patient or patient's representative signs a written informed consent form before enrollment.
✓. Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;
✓. The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow \<30% on CT perfusion or an apparent diffusion coefficient \<620×10\^-6 mm2/s on MRI).
Exclusion criteria
✕. CT or MRI evidence of acute intracranial hemorrhage;
✕. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
✕. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;