Endovascular Treatment for eXtra-Large Ischemic Stroke
ConditionStroke, Acute Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongming Qiu
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
CT or MR evidence of hemorrhage;
Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
Trial design
Treatments tested in this trial
- Medical management
- Endovascular thrombectomy
Treatment groups
286 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
The First Affiliated Hospital of University of South China
Collaborator
Xiangtan Central Hospital
Collaborator
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Collaborator
Longyan First Affiliated Hospital of Fujian Medical University
Collaborator
Taizhou First People's Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Source ClinicalTrials.gov