Efficacy and Safety of 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, Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

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

• Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;

• Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if \> 6 hours or unknown last known well time;

• Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;

• Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;

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

Locations
Other Locations
China
The First Affiliated Hospital, Hengyang Medical School, University of South China
RECRUITING
Hengyang
Xiangtan Central Hospital
RECRUITING
Xiangtan
Contact Information
Primary
Zhongfan Ruan
ruanzhongfan@sina.com
15616320002
Backup
Zhongming Qiu
qiuzhongmingdoctor@163.com
13236599269
Time Frame
Start Date: 2024-06-16
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 286
Treatments
Experimental: Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
Active_comparator: Medical management
Patients in this group will be treated with medical management alone
Related Therapeutic Areas
Sponsors
Collaborators: Longyan First Affiliated Hospital of Fujian Medical University, Xiangtan Central Hospital, Taizhou First People's Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital, University of South China, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Leads: Zhongming Qiu

This content was sourced from clinicaltrials.gov