Stroke, Acute IschemicXL STROKE-2NCT06388148
Endovascular Treatment for eXtra-Large Ischemic Stroke
A study testing Medical management and Endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Zhongming Qiu at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Medical management and Endovascular thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jun 2024to 31 Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
- 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;
- Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
- Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
- The patient or patient's representative signs a written informed consent form.
Who cannot join
- CT or MR evidence of hemorrhage;
- Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
- Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
- History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- Currently participating in another investigational drug study;
- Any terminal illness with life expectancy less than 6 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan
Zhongfan Ruan, ruanzhongfan@sina.com
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 421001
Guangxiong Yuan, 18973223018, yuanguangxiong74@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Medical management, 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 managementDrug
Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
Endovascular thrombectomyProcedure or surgery
Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular thrombectomy | Experimental | Patients in this group will be treated with medical management plus endovascular thrombectomy Receives: Drug: Medical management; Procedure: Endovascular thrombectomy |
| Medical management | Active comparator | Patients in this group will be treated with medical management alone Receives: Drug: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score
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
Measured: 90 days after randomization
Secondary outcomes (4)
Rate of successful reperfusion
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.)
Measured: Within 5 minutes at the end of angiogram
Rate of excellent outcome
Score of 0-1 on the modified Rankin scale
Measured: 90 days after randomization
Rate of functional independence
Score of 0-2 on the modified Rankin scale
Measured: 90 days after randomization
Rate of independent ambulation
Score of 0-3 on the modified Rankin scale
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start16 Jun 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Xiangtan Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Longyan City First Hospital, Taizhou First People's Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Guangxiong Yuan, Principal investigator, Xiangtan Central HospitalCongguo Yin, Principal investigator, Hangzhou First Hospital of Zhejiang UniversityTingyu Yi, Principal investigator, Zhangzhou Affiliated Hospital of Fujian Medical UniversityChong Zheng, Principal investigator, Longyan First Hospital of Fujian Medical UniversityChenghua Xu, Principal investigator, Taizhou First People's HospitalZhongfan Ruan, Principal investigator, The First Affiliated Hospital, Hengyang Medical School, University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388148
- Sponsor's protocol ID
- XL STROKE-2
- Acronym
- XL STROKE-2
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06388148
- Acronym / sponsor ID
- XL STROKE-2 / XL STROKE-2
- Conditions
- Stroke, Acute Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Xiangtan Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Longyan City First Hospital, Taizhou First People's Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular thrombectomy | Experimental | Drug: Medical management, Procedure: Endovascular thrombectomyPatients in this group will be treated with medical management plus endovascular thrombectomy |
| Medical management | Active comparator | Drug: Medical managementPatients in this group will be treated with medical management alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
- 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;
- Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
- Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
- The patient or patient's representative signs a written informed consent form.
Key exclusion criteria (6 listed)
- CT or MR evidence of hemorrhage;
- Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
- Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
- History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- Currently participating in another investigational drug study;
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 includes IV thrombolysis, antiplatelet, and/or anticoagulation. | Drug | Endovascular thrombectomy, Medical management |
| Endovascular thrombectomyEndovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting. | Procedure or surgery | Endovascular thrombectomy |
Primary outcome
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
4 secondary outcomes
Rate of successful reperfusion
Time frame: Within 5 minutes at the end of angiogram
Rate of excellent outcome
Time frame: 90 days after randomization
Rate of functional independence
Time frame: 90 days after randomization
Rate of independent ambulation
Time frame: 90 days after randomization
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 26 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
Guangxiong Yuan principal investigator
Xiangtan Central Hospital
Congguo Yin principal investigator
Hangzhou First Hospital of Zhejiang University
Tingyu Yi principal investigator
Zhangzhou Affiliated Hospital of Fujian Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical management and Endovascular thrombectomy in people with Stroke, Acute Ischemic, run by Zhongming Qiu at 2 sites 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 5 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 26 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 2 sites 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 Zhongfan Ruan (15616320002, ruanzhongfan@sina.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 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.