Clinical trial NCT01830413: Stenting for Symptomatic Intracranial Artery Stenosis Registry in China
Official title: Stenting for Symtomatic Intracranial Artery Stenosis Registry in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systematic Intracranial Artery Stenosis
Keywords: stent, systematic Intracranial artery stenosis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with systematic Intracranial artery stenosis for stenting procedure

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety during peri-operation period
timeFrame: 30 days after operation
Secondary outcomes:
measure: Recurrent stroke in 30days to 1 year after stenting in target vessel area.
timeFrame: 30days to 1 year after stenting
measure: Successful recanalization rate right after stenting
timeFrame: right after stenting
measure: Stent restenosis rate
timeFrame: Within 1 year after stenting
measure: Ischemic stroke outside target vessel area
timeFrame: 30 days - 1 year after stenting
measure: Cerebral haemorrhage
timeFrame: 30 days - 1year after
measure: Myocardial infarction
timeFrame: within 1 year
measure: non-stroke haemorrhage
timeFrame: within 1year
measure: Death in 30 days- 1 year after stenting
timeFrame: 30 days- 1 year after stenting
measure: disabled stroke
timeFrame: within 1year
measure: Any stroke or death
timeFrame: within 1 year
measure: Serious adverse event
timeFrame: within 1year
measure: National Institutes of Health Stroke Scale score(NIHSS score)
timeFrame: at 30 days and 1 year after stenting
measure: Modified Rankin score(mRS)
timeFrame: at 30 days and 1 year after stenting
measure: MoCA scale score
timeFrame: at 30 days and 1 year after stenting
measure: Life quality scale score
timeFrame: at 1 year after stenting
Other outcomes:
Locations:
city: Beiing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Tiantan Hospital
name: Zhongrong Miao, M.D.
role: STUDY_CHAIR
References: