Menu
Recruiting NCT06210633

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

— Observational Acute Ischemic Stroke (AIS) Acute Ischemic Stroke From Large Vessel Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: medical management, endovascular thrombectomy.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion

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 (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.

Interventions

  • Other medical management
    Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.
  • Other endovascular thrombectomy
    The use of devices (i.e. stent-retriever, aspiration catheter) is at the discretion of neurointerventionalist. Intra-arterial administration of alteplase, tenecteplase, tirofiban, angioplasty and stenting will also be permitted.

Primary outcome measures

  • Modified Rankin Scale score [Time frame: 90±14 days after enrollment]
Secondary outcome measures (12)
  • Independent ambulation [Time frame: 90±14 days after enrollment]
  • Not ambulatory nor capable of body self-care [Time frame: 90±14 days after enrollment]
  • Functional independence [Time frame: 90±14 days after enrollment]
  • Excellent outcome [Time frame: 90±14 days after enrollment]
  • National Institutes of Health Stroke Scale score [Time frame: 5-7 days after enrollment or discharge (whichever occurred first)]
  • Health-related quality of life [Time frame: 90±14 days after enrollment]
  • Incidence of symptomatic intracranial hemorrhage [Time frame: 48 hours after enrollment]
  • Incidence of any intracranial hemorrhage [Time frame: 48 hours after enrollment]
  • Incidence of decompressive hemicraniectomy [Time frame: 7 days after enrollment]
  • Mortality during hospitalization [Time frame: 7 days after enrollment]
  • Mortality [Time frame: 90±14 days after enrollment]
  • The occurrence of non-hemorrhagic serious adverse events [Time frame: through study completion, an average of 90 days]

Eligibility criteria

Inclusion criteria

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).

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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xiangtan Central Hospital — Xiangtan

Identifiers

NCT: NCT06210633 · XL STROKE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗