NCT06210633

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Zhongming Qiu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2024-01-20
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-01-18
• Last updated: 2025-12-31

Locations

1 site across 1 country: China