Endovascular Treatment for eXtra-Large Ischemic Stroke (XL STROKE-2)

December 18, 2025 updated by: Zhongming Qiu

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

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.

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.

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.

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.
Interventional

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.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Hengyang, Hunan, China
        • Recruiting
        • The First Affiliated Hospital, Hengyang Medical School, University of South China
        • Contact:
      • 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

Description

Inclusion Criteria:

  1. Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
  2. 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;
  3. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
  4. Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
  5. The patient or patient's representative signs a written informed consent form.

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. Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
  4. History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  5. Currently participating in another investigational drug study;
  6. Any terminal illness with life expectancy less than 6 months.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
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.
Active Comparator: Medical management
Patients in this group will be treated with medical management alone
Drug: Medical management
Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

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 days after randomization
Modified Rankin scale score (mRS): 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
90 days after randomization

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
Rate of successful reperfusion
Time Frame: Within 5 minutes at the end of angiogram
Final reperfusion grade of 2b-3 on eTICI scale (This 7-point compilation of TICI grades, termed the expanded TICI (eTICI), reflects all previously reported thresholds used to define reperfusion after endovascular stroke therapy. In brief, eTICI grade 0 is equivalent to no reperfusion or 0% filling of the downstream territory; eTICI 1 reflects thrombus reduction without any reperfusion of distal arteries; eTICI 2a is reperfusion in less than half or 1-49% of the territory; eTICI 2b50 is 50-66% reperfusion, exceeding the modified TICI (mTICI) 2B threshold but below the original TICI 2B cut-off point; eTICI 2b67 is 67-89% reperfusion, exceeding TICI but below TICI 2C; eTICI 2c is equivalent to TICI 2C or 90-99% reperfusion; and eTICI 3 is complete or 100% reperfusion, tantamount to TICI 3.)
Within 5 minutes at the end of angiogram
Rate of excellent outcome
Time Frame: 90 days after randomization
Score of 0-1 on the modified Rankin scale
90 days after randomization
Rate of functional independence
Time Frame: 90 days after randomization
Score of 0-2 on the modified Rankin scale
90 days after randomization
Rate of independent ambulation
Time Frame: 90 days after randomization
Score of 0-3 on the modified Rankin scale
90 days after randomization

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.
Taizhou First People's Hospital
Xiangtan Central Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Longyan First Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital, University of South China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake 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
  • Principal Investigator: Congguo Yin, Hangzhou First Hospital of Zhejiang University
  • Principal Investigator: Tingyu Yi, Zhangzhou Affiliated hospital of Fujian Medical University
  • Principal Investigator: Chong Zheng, Longyan First Hospital of Fujian Medical University
  • Principal Investigator: Chenghua Xu, Taizhou First People's Hospital
  • Principal Investigator: Zhongfan Ruan, The First Affiliated Hospital, Hengyang Medical School, University of South China

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.
June 16, 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.
October 31, 2026

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.
January 31, 2027

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).
April 21, 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.
April 24, 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.
April 29, 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 26, 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 18, 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

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-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Two 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings