Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xiangtan Central Hospital (The Affiliated Hospital of Hunan University) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular thrombectomy | Patients in this group will be treated with medical management plus endovascular thrombectomy |
| |
| Medical management | Patients in this group will be treated with guideline-based medical management alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale score | 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). | 90±14 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Independent ambulation | Score of 0-3 on the modified Rankin scale | 90±14 days after enrollment |
| Not ambulatory nor capable of body self-care | Score of 0-4 on the modified Rankin scale |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale score at 1 year | The score on the Modified Rankin Scale | One year after enrollment |
| Not ambulatory nor capable of body self-care | Score of 0-4 on the modified Rankin scale |
Inclusion Criteria:
Clinical inclusion criteria
Neuroimaging inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongming Qiu | Contact | +8613236599269 | qiuzhongmingdoctor@163.com | |
| Thanh N. Nguyen | Contact | thanh.nguyen@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Guangxiong Yuan | Xiangtan Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangtan Central Hospital | Recruiting | Xiangtan | Hunan | 421001 | China |
Study Protocol, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
3 years after the trial results are revealed
After approval of a proposal from principal investigator
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| endovascular thrombectomy | Other | 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. |
|
| 90±14 days after enrollment |
| Functional independence | Score of 0-2 on the modified Rankin scale | 90±14 days after enrollment |
| Excellent outcome | Score of 0-1 on the modified Rankin scale | 90±14 days after enrollment |
| National Institutes of Health Stroke Scale score | Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating worse neurologic deficits. | 5-7 days after enrollment or discharge (whichever occurred first) |
| Health-related quality of life | Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score] | 90±14 days after enrollment |
| Incidence of symptomatic intracranial hemorrhage | Use Heidelberg criteria to assess symptomatic intracranial hemorrhage. | 48 hours after enrollment |
| Incidence of any intracranial hemorrhage | Any intracranial hemorrhage within 48 hours | 48 hours after enrollment |
| Incidence of decompressive hemicraniectomy | Decompressive hemicraniectomy during hospitalization | 7 days after enrollment |
| Mortality during hospitalization | Death from any cause | 7 days after enrollment |
| Mortality | Death from any cause | 90±14 days after enrollment |
| The occurrence of non-hemorrhagic serious adverse events | The occurrence of non-hemorrhagic serious adverse events, such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, acute coronary syndrome, venous thrombosis. | through study completion, an average of 90 days |
| Mortality within 1 year | Death from any cause | One year after enrollment |
| One year after enrollment |
| Independent ambulation | Score of 0-3 on the modified Rankin scale | One year after enrollment |
| Functional independence | Score of 0-2 on the modified Rankin scale | One year after enrollment |
| Excellent outcome | Score of 0-1 on the modified Rankin scale | One year after enrollment |
| Health-related quality of life | Health-related quality of life [European Quality Five-Dimension Five-Level (EQ-5D-5L) scale score] | One year after enrollment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |