Xiangtan Central Hospital
Xiangtan, Hunan, 421001, China
Location status: Recruiting
NCT Number: NCT06210633
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Xiangtan, Hunan, 421001, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical inclusion criteria
Neuroimaging inclusion criteria
Exclusion criteria
Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.
The use of devices (i.e. stent-retriever, aspiration catheter) is at the discretion of neurointerventionalist. Intra-arterial administration of alteplase, tenecteplase, tirofiban, angioplasty and stenting will also be permitted.
Time frame: 90±14 days after enrollment
The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).
Time frame: 90±14 days after enrollment
Score of 0-3 on the modified Rankin scale
Time frame: 90±14 days after enrollment
Score of 0-4 on the modified Rankin scale
Time frame: 90±14 days after enrollment
Score of 0-2 on the modified Rankin scale
Time frame: 90±14 days after enrollment
Score of 0-1 on the modified Rankin scale
Time frame: 5-7 days after enrollment or discharge (whichever occurred first)
Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating worse neurologic deficits.
Time frame: 90±14 days after enrollment
Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score]
Time frame: 48 hours after enrollment
Use Heidelberg criteria to assess symptomatic intracranial hemorrhage.
Time frame: 48 hours after enrollment
Any intracranial hemorrhage within 48 hours
Time frame: 7 days after enrollment
Decompressive hemicraniectomy during hospitalization
Time frame: 7 days after enrollment
Death from any cause
Time frame: 90±14 days after enrollment
Death from any cause
Time frame: through study completion, an average of 90 days
The occurrence of non-hemorrhagic serious adverse events, such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, acute coronary syndrome, venous thrombosis.
Time frame: One year after enrollment
Death from any cause
Time frame: One year after enrollment
The score on the Modified Rankin Scale
Time frame: One year after enrollment
Score of 0-4 on the modified Rankin scale
Time frame: One year after enrollment
Score of 0-3 on the modified Rankin scale
Time frame: One year after enrollment
Score of 0-2 on the modified Rankin scale
Time frame: One year after enrollment
Score of 0-1 on the modified Rankin scale
Time frame: One year after enrollment
Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score]
Contact information is provided by the study sponsor or research team.
Zhongming Qiu
Other
XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion
Acronym: XL-STROKE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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