Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

NCT ID: NCT06210633

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2026-03-31

Brief 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 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.

Conditions

Acute Ischemic Stroke (AIS); Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

Acute ischemic stroke; large vessel occlusion; endovascular thrombectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endovascular thrombectomy

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

medical management

Intervention Type: OTHER

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 thrombectomy

Intervention Type: OTHER

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

medical management

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

UNKNOWN

Sponsor Role: collaborator

Zhongming Qiu

OTHER

Sponsor Role: lead

Responsible Party

Zhongming Qiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guangxiong Yuan

Role: PRINCIPAL_INVESTIGATOR

Xiangtan Central Hospital

Locations

Xiangtan Central Hospital

Xiangtan, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongming Qiu

Role: CONTACT

Phone: +8613236599269

Email: qiuzhongmingdoctor@163.com

Thanh N. Nguyen

Role: CONTACT

Email: thanh.nguyen@bmc.org

Facility Contacts

Guangxiong Yuan

Role: primary

Other Identifiers

XL STROKE

Identifier Type: -

Identifier Source: org_study_id