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

Zhongming Qiu

Status: Enrolling

Conditions: Stroke, Acute

Treatments: Other: endovascular thrombectomy; Other: medical management

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 (volume greater than 100 mL, 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: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical inclusion criteria:

1. Acute ischemic stroke within 24 hours from onset to enrollment;

2. The patient or patient's representative signs a written informed consent form;

   Imaging inclusion criteria:

3. If the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery M1 or M2, or the anterior cerebral artery A1, the baseline ASPECTS is 0 to 2 based on NCCT, or cerebral infarction core volume ≥85ml based on CT perfusion.

4. If the occlusion site is located in the vertebrobasilar artery, then the baseline pc-ASPECTS is 0 to 5.

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. Currently pregnancy;
4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
5. Any terminal illness with life expectancy less than 6 months.

Trial design

600 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 medical management alone

Treatment:

Other: medical management