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A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.
This trial aims to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window. The study used a stratified block randomization method, with stratification by center. A central randomization system was used to assign subjects to the experimental group and the control group in a 2:1 ratio for each center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Therapy Group | Experimental | Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods. |
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| Best Medical Management Group | No Intervention | Participants receive best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Treatment | Procedure | Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization. | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (±7)days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization. | Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories. | 90 (±7) days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracerebral haemorrhage (sICH) within 24 (±6) hours after randomization (Heidelberg bleeding classification). | Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 24 (±6) hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death, and cerebral herniation, which were not present at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianjun Huang, PhD | Contact | 8618130333940 | doctorhuangxj@hotmail.com | |
| Wen Sun, PhD | Contact | 8615050589620 | sunwen_medneuro@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Wannan Medical College | Recruiting | Wuhu | Anhui | 241000 | China |
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| Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization. | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (±7) days after procedure |
| Change in NIHSS score from baseline at 24 hours postoperatively. | The NIHSS (National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke. | 24 hours after procedure |
| EQ-5D-5L scale at 90 (±7) days after randomization. | The EQ-5D-5L scale is a standardized tool used to measure a person's health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels to indicate the severity of problems in those areas. | 90 (±7) days after procedure |
| Change in NIHSS score from baseline at discharge or 5-7 days postoperatively. | The NIHSS (National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke. | Discharge or 5 -7 days after procedure. |
| Successful reperfusion postoperatively. | The eTICI (extended Thrombolysis in Cerebral Infarction) score is a standard used to evaluate the degree of reperfusion in acute ischemic stroke patients following endovascular therapy (EVT). It is a further refinement of the mTICI (modified TICI) score. | At the end of the operation |
| Within 24 (±6) hours after procedure |
| Incidence of any intracerebral haemorrhage within 24 (±6) hours after randomization (Heidelberg bleeding classification). | Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 24 (±6) hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. | within 24 (±6) hours after procedure |
| All-cause mortality at 90 (±7) days after randomization. | All-cause mortality refers to the rate of death from any cause within a specific time period, without considering the underlying cause of death. | 90 (±7) days after procedure |