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

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: Recruiting
• Conditions: Acute Ischemic Stroke From Large Vessel Occlusion; Acute Ischemic Stroke (AIS)
• Intervention / Treatment: Other: medical management; Other: endovascular thrombectomy

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Zhongming Qiu; Phone Number: +8613236599269; Email: qiuzhongmingdoctor@163.com
• Study Contact Backup: Name: Thanh N. Nguyen; Email: thanh.nguyen@bmc.org

Study Locations

• China
  • Hunan
    • Xiangtan, Hunan, China, 421001
      • Recruiting
      • Xiangtan Central Hospital
      • Contact: Guangxiong Yuan; Phone Number: 18973223018; Email: yuanguangxiong74@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale score	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

Outcome Measure	Measure Description	Time Frame
Independent ambulation	Score of 0-3 on the modified Rankin scale	90±14 days after enrollment
Not ambulatory nor capable of body self-care	Score of 0-4 on the modified Rankin scale	90±14 days after enrollment
Functional independence	Score of 0-2 on the modified Rankin scale	90±14 days after enrollment
Excellent outcome	Score of 0-1 on the modified Rankin scale	90±14 days after enrollment
National Institutes of Health Stroke Scale score	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	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	Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.	48 hours after enrollment
Incidence of any intracranial hemorrhage	Any intracranial hemorrhage within 48 hours	48 hours after enrollment
Incidence of decompressive hemicraniectomy	Decompressive hemicraniectomy during hospitalization	7 days after enrollment
Mortality during hospitalization	Death from any cause	7 days after enrollment
Mortality	Death from any cause	90±14 days after enrollment
The occurrence of non-hemorrhagic serious adverse events	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	Death from any cause	One year after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale score at 1 year	The score on the Modified Rankin Scale	One year after enrollment
Not ambulatory nor capable of body self-care	Score of 0-4 on the modified Rankin scale	One year after enrollment
Independent ambulation	Score of 0-3 on the modified Rankin scale	One year after enrollment
Functional independence	Score of 0-2 on the modified Rankin scale	One year after enrollment
Excellent outcome	Score of 0-1 on the modified Rankin scale	One year after enrollment
Health-related quality of life	Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score]	One year after enrollment

Collaborators and Investigators

• Sponsor: Zhongming Qiu
• Collaborators: Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
• Investigators: Principal Investigator: Guangxiong Yuan, Xiangtan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; large vessel occlusion; endovascular thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Professional Practice; Organization and Administration; Health Services Administration; Practice Management; Practice Management, Medical
• Other Study ID 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