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Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Recruiting
years of age
Both
Phase N/A

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Overview

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 (volume greater than 100 mL, 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.

Eligibility

Inclusion Criteria:

Clinical inclusion criteria:

  1. Acute ischemic stroke within 24 hours from onset to enrollment;
  2. The patient or patient's representative signs a written informed consent form;

    Imaging inclusion criteria:

  3. If the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery M1 or M2, or the anterior cerebral artery A1, the baseline ASPECTS is 0 to 2 based on NCCT, or cerebral infarction core volume ≥85ml based on CT perfusion.
  4. If the occlusion site is located in the vertebrobasilar artery, then the baseline pc-ASPECTS is 0 to 5.

Exclusion Criteria:

  1. CT or MR evidence of hemorrhage;
  2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
  3. Currently pregnancy;
  4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  5. Any terminal illness with life expectancy less than 6 months.

Study details

Stroke, Acute

NCT06210633

Zhongming Qiu

30 April 2024

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