Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion
Conditions
Keywords
Acute ischemic stroke, large vessel occlusion, endovascular thrombectomy
Brief 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 (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.
Interventions
OTHERmedical management
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.
OTHERendovascular thrombectomy
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.
Sponsors
Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
Zhongming Qiu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical inclusion criteria 1. Age ≥18 years; 2. Presenting with acute ischemic stroke within 24 hours of time from last known well; 3. The patient or patient's representative signs a written informed consent form before enrollment. Neuroimaging inclusion criteria 1. Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography; 2. The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow \<30% on CT perfusion or an apparent diffusion coefficient \<620×10\^-6 mm2/s on MRI).
Exclusion criteria
1. CT or MRI evidence of acute intracranial hemorrhage; 2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging; 3. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test; 4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis; 5. Any terminal illness with life expectancy less than 6 months; 6. Participation in other clinical treatment trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale score | 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. |
| Incidence of any intracranial hemorrhage | 48 hours after enrollment | Any intracranial hemorrhage within 48 hours |
| Incidence of decompressive hemicraniectomy | 7 days after enrollment | Decompressive hemicraniectomy during hospitalization |
| Mortality during hospitalization | 7 days after enrollment | Death from any cause |
| Mortality | 90±14 days after enrollment | Death from any cause |
| The occurrence of non-hemorrhagic serious adverse events | 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. |
| Mortality within 1 year | One year after enrollment | Death from any cause |
| Independent ambulation | 90±14 days after enrollment | Score of 0-3 on the modified Rankin scale |
| Not ambulatory nor capable of body self-care | 90±14 days after enrollment | Score of 0-4 on the modified Rankin scale |
| Functional independence | 90±14 days after enrollment | Score of 0-2 on the modified Rankin scale |
| Excellent outcome | 90±14 days after enrollment | Score of 0-1 on the modified Rankin scale |
| Health-related quality of life | 90±14 days after enrollment | Health-related quality of life \[European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score\] |
| Incidence of symptomatic intracranial hemorrhage | 48 hours after enrollment | Use Heidelberg criteria to assess symptomatic intracranial hemorrhage. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Independent ambulation | One year after enrollment | Score of 0-3 on the modified Rankin scale |
| Functional independence | One year after enrollment | Score of 0-2 on the modified Rankin scale |
| Excellent outcome | One year after enrollment | Score of 0-1 on the modified Rankin scale |
| Health-related quality of life | One year after enrollment | Health-related quality of life \[European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score\] |
| Modified Rankin Scale score at 1 year | One year after enrollment | The score on the Modified Rankin Scale |
| Not ambulatory nor capable of body self-care | One year after enrollment | Score of 0-4 on the modified Rankin scale |
Countries
China
Contacts
Primary ContactZhongming Qiu
Backup ContactThanh N. Nguyen
Outcome results
None listed