Endovascular Treatment for eXtra-Large Ischemic Stroke
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
Zhongming Qiu
286 participants
Jun 16, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria6
- 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;
- Currently participating in another investigational drug study;
- Any terminal illness with life expectancy less than 6 months.
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Interventions
Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06388148