Systematic Intracranial Artery Stenosis Clinical Trial
Official title:
Stenting for Symtomatic Intracranial Artery Stenosis Registry in China
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.
| Status | Not yet recruiting |
| Enrollment | 450 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tiantan Hospital | Beiing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tiantan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | Successful recanalization rate right after stenting | right after stenting | No | |
| Secondary | Stent restenosis rate | Within 1 year after stenting | No | |
| Secondary | Ischemic stroke outside target vessel area | 30 days - 1 year after stenting | No | |
| Secondary | Cerebral haemorrhage | 30 days - 1year after | Yes | |
| Secondary | Myocardial infarction | within 1 year | Yes | |
| Secondary | non-stroke haemorrhage | within 1year | Yes | |
| Secondary | Death in 30 days- 1 year after stenting | 30 days- 1 year after stenting | Yes | |
| Secondary | disabled stroke | within 1year | Yes | |
| Secondary | Any stroke or death | within 1 year | Yes | |
| Secondary | Serious adverse event | within 1year | Yes | |
| Secondary | National Institutes of Health Stroke Scale score(NIHSS score) | at 30 days and 1 year after stenting | No | |
| Secondary | Modified Rankin score(mRS) | at 30 days and 1 year after stenting | No | |
| Secondary | MoCA scale score | at 30 days and 1 year after stenting | No | |
| Secondary | Life quality scale score | at 1 year after stenting | No |