Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

NCT ID: NCT01830413

Last Updated: 2013-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Systematic Intracranial Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stenting

cerebral artery stenting for systematic Intracranial artery stenosis

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongrong Miao

Doc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongrong Miao, M.D.

Role: STUDY_CHAIR

Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beiing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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yilong Wang, M.D.

Role: CONTACT

86-13911666571

Facility Contacts

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Yilong Wang, M.D.

Role: primary

Other Identifiers

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stent-2013

Identifier Type: -

Identifier Source: org_study_id

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