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Endovascular Treatment for eXtra-Large Ischemic Stroke

NCT ID: NCT06388148

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-16

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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Stroke, Acute Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endovascular thrombectomy

Patients in this group will be treated with medical management plus endovascular thrombectomy

Group Type EXPERIMENTAL

Medical management

Intervention Type DRUG

Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

Endovascular thrombectomy

Intervention Type PROCEDURE

Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Medical management

Patients in this group will be treated with medical management alone

Group Type ACTIVE_COMPARATOR

Medical management

Intervention Type DRUG

Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

Interventions

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Medical management

Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

Intervention Type DRUG

Endovascular thrombectomy

Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital, University of South China

UNKNOWN

Sponsor Role collaborator

Xiangtan Central Hospital

OTHER

Sponsor Role collaborator

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

UNKNOWN

Sponsor Role collaborator

Longyan First Affiliated Hospital of Fujian Medical University

UNKNOWN

Sponsor Role collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Zhongming Qiu

OTHER

Sponsor Role lead

Responsible Party

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Zhongming Qiu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guangxiong Yuan

Role: PRINCIPAL_INVESTIGATOR

Xiangtan Central Hospital

Congguo Yin

Role: PRINCIPAL_INVESTIGATOR

Hangzhou First Hospital of Zhejiang University

Tingyu Yi

Role: PRINCIPAL_INVESTIGATOR

Zhangzhou Affiliated Hospital of Fujian Medical University

Chong Zheng

Role: PRINCIPAL_INVESTIGATOR

Longyan First Hospital of Fujian Medical University

Chenghua Xu

Role: PRINCIPAL_INVESTIGATOR

Taizhou First People's Hospital

Zhongfan Ruan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Hengyang Medical School, University of South China

Locations

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The First Affiliated Hospital, Hengyang Medical School, University of South China

Hengyang, Hunan, China

Site Status RECRUITING

Xiangtan Central Hospital

Xiangtan, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhongfan Ruan

Role: CONTACT

Phone: 15616320002

Email: [email protected]

Zhongming Qiu

Role: CONTACT

Phone: 13236599269

Email: [email protected]

Facility Contacts

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Zhongfan Ruan

Role: primary

Guangxiong Yuan

Role: primary

Other Identifiers

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XL STROKE-2

Identifier Type: -

Identifier Source: org_study_id