Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

• Conditions: Systematic Intracranial Artery Stenosis

• Registration Number: NCT01830413
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety during peri-operation period	30 days after operation	Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis

Secondary Outcome Measures

Name	Time	Method
Any stroke or death	within 1 year
Serious adverse event	within 1year
Death in 30 days- 1 year after stenting	30 days- 1 year after stenting
disabled stroke	within 1year
Recurrent stroke in 30days to 1 year after stenting in target vessel area.	30days to 1 year after stenting	Recurrent stroke in 30days to 1 year after stenting in target vessel area.
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
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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beiing, Beijing, China