Acute Ischemic Stroke (AIS)XL-STROKENCT06210633
Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke
An observational study of Acute Ischemic Stroke (AIS) and Acute Ischemic Stroke From Large Vessel Occlusion, run by Zhongming Qiu at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- medical management and endovascular thrombectomy
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 31 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thanh N. Nguyen contact
China1 site, 1 recruiting
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 421001
Guangxiong Yuan, 18973223018, yuanguangxiong74@163.com
About this study
Official title: 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.
- Being tested
- medical management, endovascular thrombectomy
- Keywords
- Acute ischemic stroke, large vessel occlusion, endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical managementOther
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 thrombectomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular thrombectomy | Patients in this group will be treated with medical management plus endovascular thrombectomy Receives: Other: medical management; Other: endovascular thrombectomy | |
| Medical management | Patients in this group will be treated with guideline-based medical management alone Receives: Other: medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90±14 days after enrollment
Secondary outcomes (13)
Independent ambulation
Score of 0-3 on the modified Rankin scale
Measured: 90±14 days after enrollment
Not ambulatory nor capable of body self-care
Score of 0-4 on the modified Rankin scale
Measured: 90±14 days after enrollment
Functional independence
Score of 0-2 on the modified Rankin scale
Measured: 90±14 days after enrollment
Excellent outcome
Score of 0-1 on the modified Rankin scale
Measured: 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.
Measured: 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]
Measured: 90±14 days after enrollment
Incidence of symptomatic intracranial hemorrhage
Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.
Measured: 48 hours after enrollment
Incidence of any intracranial hemorrhage
Any intracranial hemorrhage within 48 hours
Measured: 48 hours after enrollment
Incidence of decompressive hemicraniectomy
Decompressive hemicraniectomy during hospitalization
Measured: 7 days after enrollment
Mortality during hospitalization
Death from any cause
Measured: 7 days after enrollment
Mortality
Death from any cause
Measured: 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.
Measured: through study completion, an average of 90 days
Mortality within 1 year
Death from any cause
Measured: One year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Guangxiong Yuan, Principal investigator, Xiangtan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210633
- Sponsor's protocol ID
- XL STROKE
- Acronym
- XL-STROKE
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Yuan G, Liu L, Liang Y, Wu J, Nguyen TN, Wei S, Cui T, Li X, Yuan Z, Liu S, Zeng G, Ruan Z, Zheng C, Tan X, Tang S, Hao H, Xia H, Nogueira RG, Thomalla G, Campbell B, Saver JL, Yang Q, Long C, Qiu Z, Sang H. A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-Large Ischemic Stroke with Large Vessel Occlusion (XL STROKE): Rationale and Design. Cerebrovasc Dis. 2025;54(6):894-900. doi: 10.1159/000544844. Epub 2025 Feb 25.
PubMed 39999799
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT06210633
- Acronym / sponsor ID
- XL-STROKE / XL STROKE
- Keywords
- Acute ischemic stroke, large vessel occlusion, endovascular thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Collaborators
- Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular thrombectomy | – | Other: medical management, Other: endovascular thrombectomyPatients in this group will be treated with medical management plus endovascular thrombectomy |
| Medical management | – | Other: medical managementPatients in this group will be treated with guideline-based medical management alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical managementMedical 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, Medical management |
| endovascular thrombectomyThe 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. | Other | Endovascular thrombectomy |
Primary outcome
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).
13 secondary outcomes
Independent ambulation
Time frame: 90±14 days after enrollment
Not ambulatory nor capable of body self-care
Time frame: 90±14 days after enrollment
Functional independence
Time frame: 90±14 days after enrollment
Excellent outcome
Time frame: 90±14 days after enrollment
National Institutes of Health Stroke Scale score
Time frame: 5-7 days after enrollment or discharge (whichever occurred first)
Health-related quality of life
Time frame: 90±14 days after enrollment
Incidence of symptomatic intracranial hemorrhage
Time frame: 48 hours after enrollment
Incidence of any intracranial hemorrhage
Time frame: 48 hours after enrollment
Incidence of decompressive hemicraniectomy
Time frame: 7 days after enrollment
Mortality during hospitalization
Time frame: 7 days after enrollment
Mortality
Time frame: 90±14 days after enrollment
The occurrence of non-hemorrhagic serious adverse events
Time frame: through study completion, an average of 90 days
Mortality within 1 year
Time frame: One year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 39999799Yuan G, Liu L, Liang Y, Wu J, Nguyen TN, Wei S, Cui T, Li X, Yuan Z, Liu S, Zeng G, Ruan Z, Zheng C, Tan X, Tang S, Hao H, Xia H, Nogueira RG, Thomalla G, Campbell B, Saver JL, Yang Q, Long C, Qiu Z, Sang H. A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-Large Ischemic Stroke with Large Vessel Occlusion (XL STROKE): Rationale and Design. Cerebrovasc Dis. 2025;54(6):894-900. doi: 10.1159/000544844. Epub 2025 Feb 25.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanh N. Nguyen contact
Guangxiong Yuan principal investigator
Xiangtan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke (AIS) and Acute Ischemic Stroke From Large Vessel Occlusion, run by Zhongming Qiu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongming Qiu (+8613236599269, qiuzhongmingdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale score (time frame: 90±14 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.