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NCT Number: NCT06210633

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangtan Central Hospital

Xiangtan, Hunan, 421001, China

Location status: Recruiting

Location contact

Guangxiong Yuan

CONTACT

[email protected]

18973223018

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical management

Other

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.

endovascular thrombectomy

Other

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 outcomes

  1. Modified Rankin Scale score

    Time frame: 90±14 days after enrollment

    The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).

Secondary outcomes

  1. Independent ambulation

    Time frame: 90±14 days after enrollment

    Score of 0-3 on the modified Rankin scale

  2. Not ambulatory nor capable of body self-care

    Time frame: 90±14 days after enrollment

    Score of 0-4 on the modified Rankin scale

  3. Functional independence

    Time frame: 90±14 days after enrollment

    Score of 0-2 on the modified Rankin scale

  4. Excellent outcome

    Time frame: 90±14 days after enrollment

    Score of 0-1 on the modified Rankin scale

  5. National Institutes of Health Stroke Scale score

    Time frame: 5-7 days after enrollment or discharge (whichever occurred first)

    Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating worse neurologic deficits.

  6. Health-related quality of life

    Time frame: 90±14 days after enrollment

    Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score]

  7. Incidence of symptomatic intracranial hemorrhage

    Time frame: 48 hours after enrollment

    Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.

  8. Incidence of any intracranial hemorrhage

    Time frame: 48 hours after enrollment

    Any intracranial hemorrhage within 48 hours

  9. Incidence of decompressive hemicraniectomy

    Time frame: 7 days after enrollment

    Decompressive hemicraniectomy during hospitalization

  10. Mortality during hospitalization

    Time frame: 7 days after enrollment

    Death from any cause

  11. Mortality

    Time frame: 90±14 days after enrollment

    Death from any cause

  12. The occurrence of non-hemorrhagic serious adverse events

    Time frame: through study completion, an average of 90 days

    The occurrence of non-hemorrhagic serious adverse events, such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, acute coronary syndrome, venous thrombosis.

  13. Mortality within 1 year

    Time frame: One year after enrollment

    Death from any cause

Other outcomes

  1. Modified Rankin Scale score at 1 year

    Time frame: One year after enrollment

    The score on the Modified Rankin Scale

  2. Not ambulatory nor capable of body self-care

    Time frame: One year after enrollment

    Score of 0-4 on the modified Rankin scale

  3. Independent ambulation

    Time frame: One year after enrollment

    Score of 0-3 on the modified Rankin scale

  4. Functional independence

    Time frame: One year after enrollment

    Score of 0-2 on the modified Rankin scale

  5. Excellent outcome

    Time frame: One year after enrollment

    Score of 0-1 on the modified Rankin scale

  6. Health-related quality of life

    Time frame: One year after enrollment

    Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score]

Study contacts

Contact information is provided by the study sponsor or research team.

Thanh N. Nguyen

CONTACT

[email protected]

Zhongming Qiu

CONTACT

[email protected]

+8613236599269

Sponsors and collaborators

Lead sponsor

Zhongming Qiu

Other

Collaborators

  • Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

Registry information

Official study title

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

Acronym: XL-STROKE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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