Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Recruiting now

Conditions studied: Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion

In brief

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.

Key facts

Study ID

NCT06210633

Run by

Zhongming Qiu

People needed

1000

Starts

2024-01-20

Expected to finish

2026-03-31

Last updated by the study team

2025-12-31

Who can join

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

You may qualify if…

• Clinical 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.
• Neuroimaging inclusion criteria
• 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).

You may not qualify if…

• 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;
• Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
• Any terminal illness with life expectancy less than 6 months;
• Participation in other clinical treatment trials.

Where it is running

• Xiangtan Central Hospital — Xiangtan, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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