Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study

Study Overview
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Brief Summary
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The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.

Official Title
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Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study

Conditions
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Intracranial Atherosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants had a symptomatic intracranial stenosis of 70-99 percentage (%) with a lesion length of ≤15 mm and target vessel diameter of ≥2.0 mm in the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries and the measurements of stenosis will be made on magnetic resonance angiography (MRA) using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial method and confirmed by digital subtraction angiography (DSA). Presented with transient ischemic attack (TIA) or stroke within the past 12 months attributed to the stenosis. Exclusion Criteria: Participants with acute infarctions within the past 3 weeks. Severe arterial tortuosity prevents the deployment of endovascular devices. Non-atherosclerotic lesion on magnetic resonance imaging (MRI), embolic or perforator stroke on MRI or computerized tomography (CT). A baseline modified Rankin Scale (mRS) score of >3. Massive cerebral infarction (>1/2 middle cerebral artery (MCA) territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular events | Any stroke (including ischemic or hemorrhagic stroke) or TIA after stenting within the territory of the target vessel. | 30 days after stenting | 
| Death | Death after stenting within the territory of target vessel. | 30 days after stenting | 
| Cerebrovascular events | Ischemic or hemorrhagic stroke within the territory of the target vessel. | 30 days to1 year after stenting | 
| Death | Vascular death after stenting within the territory of target vessel | 30 days to1 year after stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | During the peri-operative period, complications such as vasospasms, acute thrombosis, vascular rupture, cerebral infarction, and cerebral haemorrhage will be recorded. | Peri-operative period | 
| Number of participants with restenosis | Magnetic resonance angiography (MRA) will be used to calculate the number and incidence of restenosis among all participants. | 1 year after stenting | 
| The degree of restenosis of the target vessel | The degree of restenosis will be assessed by performing magnetic resonance angiography (MRA) using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial method for the measurements of arterial stenosis. | 1 year after stenting | 
| Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score | The National Institutes of Health Stroke Scale (NIHSS) score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function. | Baseline and 30 days after stenting | 
| Change from baseline in modified Rankin Scale (mRS) score | The modified Rankin Scale (mRS) score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.it ranges from 0 to 6 .The higher the mRS score, the worse the prognosis. | Baseline and 30 days after stenting | 
| Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score | The National Institutes of Health Stroke Scale (NIHSS) score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function. | Baseline and 1 year after stenting | 
| Change from baseline in modified Rankin Scale (mRS) score | The modified Rankin Scale (mRS) score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.it ranges from 0 to 6 .The higher the mRS score, the worse the prognosis. | Baseline and 1 year after stenting |