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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Clinical inclusion criteria

• Age ≥18 years;

• Presenting with acute ischemic stroke within 24 hours of time from last known well;

• The patient or patient's representative signs a written informed consent form before enrollment.

⁃ Neuroimaging inclusion criteria

• 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;

• 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).

Locations
Other Locations
China
Xiangtan Central Hospital
RECRUITING
Xiangtan
Contact Information
Primary
Zhongming Qiu
qiuzhongmingdoctor@163.com
+8613236599269
Backup
Thanh N. Nguyen
thanh.nguyen@bmc.org
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 1000
Treatments
Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
Medical management
Patients in this group will be treated with guideline-based medical management alone
Related Therapeutic Areas
Sponsors
Collaborators: Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
Leads: Zhongming Qiu

This content was sourced from clinicaltrials.gov

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