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Recruiting NCT06388148

Endovascular Treatment for eXtra-Large Ischemic Stroke

No phase Interventional Stroke, Acute Ischemic

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: Stroke, Acute Ischemic. 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

Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial

Overview

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Detailed description

Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular 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 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Interventions

  • Drug Medical management
    Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
  • Procedure Endovascular thrombectomy
    Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Primary outcome measures

  • Modified Rankin Scale score [Time frame: 90 days after randomization]
Secondary outcome measures (4)
  • Rate of successful reperfusion [Time frame: Within 5 minutes at the end of angiogram]
  • Rate of excellent outcome [Time frame: 90 days after randomization]
  • Rate of functional independence [Time frame: 90 days after randomization]
  • Rate of independent ambulation [Time frame: 90 days after randomization]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
  • Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if > 6 hours or unknown last known well time;
  • Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
  • Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
  • The patient or patient's representative signs a written informed consent form.

Exclusion criteria

  • CT or MR evidence of hemorrhage;
  • Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
  • Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
  • History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  • Currently participating in another investigational drug study;
  • Any terminal illness with life expectancy less than 6 months.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The First Affiliated Hospital, Hengyang Medical School, University of South China — Hengyang
  • Xiangtan Central Hospital — Xiangtan

Identifiers

NCT: NCT06388148 · XL STROKE-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗