Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

Study Overview
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Brief Summary
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Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.

Official Title
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Stenting for Symtomatic Intracranial Artery Stenosis Registry in China

Conditions
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Systematic Intracranial Artery Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 year old medical failure patient with systematic Intracranial artery stenosis More than 3 weeks after most recent ischemic stroke Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery Imaging test within 1 week showed bad collateral circulation in target vessel area Diseased vessel diameter≥2mm, length <15mm, distal vessel is normal Exclusion Criteria: Diffused intracranial stenosis Acute stroke or TIA within 3 weeks Pure penetrating branch stenosis showed by cerebral imaging Non-atherosclerosis pathology for the stenosis Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation •>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin <10g/dl，platelet count <100000 Modified Rankin score ≥3 related to target vessel; INR(International Normalized Ratio)>1.5(irreversible），persist hemorrhage risk; life expectancy < 1year Pregnant or beast-feeding Not suitable for endovascular stenting judged by Indication Judgement Committee

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stenting<br>cerebral artery stenting for systematic Intracranial artery stenosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during peri-operation period | Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke in 30days to 1 year after stenting in target vessel area. | Recurrent stroke in 30days to 1 year after stenting in target vessel area. | 30days to 1 year after stenting | 
| Successful recanalization rate right after stenting |  | right after stenting | 
| Stent restenosis rate |  | Within 1 year after stenting | 
| Ischemic stroke outside target vessel area |  | 30 days - 1 year after stenting | 
| Cerebral haemorrhage |  | 30 days - 1year after | 
| Myocardial infarction |  | within 1 year | 
| non-stroke haemorrhage |  | within 1year | 
| Death in 30 days- 1 year after stenting |  | 30 days- 1 year after stenting | 
| disabled stroke |  | within 1year | 
| Any stroke or death |  | within 1 year | 
| Serious adverse event |  | within 1year | 
| National Institutes of Health Stroke Scale score(NIHSS score) |  | at 30 days and 1 year after stenting | 
| Modified Rankin score(mRS) |  | at 30 days and 1 year after stenting | 
| MoCA scale score |  | at 30 days and 1 year after stenting | 
| Life quality scale score |  | at 1 year after stenting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, systematic Intracranial artery stenosis