Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke (XL-STROKE)

December 24, 2025 updated by: Zhongming Qiu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Xiangtan, Hunan, China, 421001
        • Recruiting
        • Xiangtan Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.

Description

Inclusion Criteria:

Clinical inclusion criteria

  1. Age ≥18 years;
  2. Presenting with acute ischemic stroke within 24 hours of time from last known well;
  3. The patient or patient's representative signs a written informed consent form before enrollment.

Neuroimaging inclusion criteria

  1. 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;
  2. 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

  1. CT or MRI evidence of acute intracranial hemorrhage;
  2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
  3. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
  4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  5. Any terminal illness with life expectancy less than 6 months;
  6. Participation in other clinical treatment trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
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.
Medical management
Patients in this group will be treated with guideline-based medical management alone
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
90±14 days after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Independent ambulation
Time Frame: 90±14 days after enrollment
Score of 0-3 on the modified Rankin scale
90±14 days after enrollment
Not ambulatory nor capable of body self-care
Time Frame: 90±14 days after enrollment
Score of 0-4 on the modified Rankin scale
90±14 days after enrollment
Functional independence
Time Frame: 90±14 days after enrollment
Score of 0-2 on the modified Rankin scale
90±14 days after enrollment
Excellent outcome
Time Frame: 90±14 days after enrollment
Score of 0-1 on the modified Rankin scale
90±14 days after enrollment
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.
5-7 days after enrollment or discharge (whichever occurred first)
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]
90±14 days after enrollment
Incidence of symptomatic intracranial hemorrhage
Time Frame: 48 hours after enrollment
Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.
48 hours after enrollment
Incidence of any intracranial hemorrhage
Time Frame: 48 hours after enrollment
Any intracranial hemorrhage within 48 hours
48 hours after enrollment
Incidence of decompressive hemicraniectomy
Time Frame: 7 days after enrollment
Decompressive hemicraniectomy during hospitalization
7 days after enrollment
Mortality during hospitalization
Time Frame: 7 days after enrollment
Death from any cause
7 days after enrollment
Mortality
Time Frame: 90±14 days after enrollment
Death from any cause
90±14 days after enrollment
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.
through study completion, an average of 90 days
Mortality within 1 year
Time Frame: One year after enrollment
Death from any cause
One year after enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale score at 1 year
Time Frame: One year after enrollment
The score on the Modified Rankin Scale
One year after enrollment
Not ambulatory nor capable of body self-care
Time Frame: One year after enrollment
Score of 0-4 on the modified Rankin scale
One year after enrollment
Independent ambulation
Time Frame: One year after enrollment
Score of 0-3 on the modified Rankin scale
One year after enrollment
Functional independence
Time Frame: One year after enrollment
Score of 0-2 on the modified Rankin scale
One year after enrollment
Excellent outcome
Time Frame: One year after enrollment
Score of 0-1 on the modified Rankin scale
One year after enrollment
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]
One year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongming Qiu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guangxiong Yuan, Xiangtan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XL STROKE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.

IPD Sharing Time Frame

3 years after the trial results are revealed

IPD Sharing Access Criteria

After approval of a proposal from principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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