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

Zhongming Qiu

Status: Enrolling

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

Treatments: Other: medical management; Other: endovascular thrombectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06210633

XL STROKE

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,000 participants in 2 patient groups

Endovascular thrombectomy

Description:

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

Treatment:

Other: endovascular thrombectomy

Other: medical management

Medical management

Description:

Patients in this group will be treated with guideline-based medical management alone

Treatment:

Other: medical management