Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Prospective Registry

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 (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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ Clinical inclusion criteria:

• Acute ischemic stroke within 24 hours from onset to enrollment;

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

• Imaging inclusion criteria:

• 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.

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

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: 2025-06-30
Participants
Target number of participants: 990
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 medical management alone
Related Therapeutic Areas
Sponsors
Collaborators: Xiangtan Central Hospital
Leads: Zhongming Qiu

This content was sourced from clinicaltrials.gov

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