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Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China

NCT ID: NCT00685308

Last Updated: 2008-05-28

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-10-31

Brief Summary

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This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.

Detailed Description

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The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.

The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).

The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.

Conditions

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Intracranial Atherosclerosis

Keywords

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Atherosclerosis Intracranial artery Angioplasty Stent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Stenting of atherosclerotic intracranial stenosis

Patients will receive aspirin 300mg and clopidogrel 75mg per day for 3 days or more before stenting,and for at least 1 month after stenting. Modifiable risk factors will be controlled according to major international guidelines.

All stenting procedures will be performed in an elective setting, and under local or general anesthesia. The study will be terminated if stroke or death rate within 30 days of the stenting exceeds 15%.

Intervention Type PROCEDURE

Other Intervention Names

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Wingspan stenting for intracranial stenosis

Eligibility Criteria

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Inclusion Criteria

* An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score \<9) within 90 days;
* the lesion length \<15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm;
* patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).

Exclusion Criteria

* Non-atherosclerotic stenosis;
* intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism;
* concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation;
* tandem \>50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin \<10 g/dl, platelet count \<100,000;
* international normalized ratio \>1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy \<1 years because of other medical conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Beijing Tiantan Hospital, The Capital Medical University (CMU)

Principal Investigators

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Wei-Jian Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital, The Capital Medical University, Beijing, China

Locations

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Beijiang Tiantan Hospital, The Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei-Jian Jiang, MD

Role: CONTACT

Phone: 86-10-6706-1935

Email: [email protected]

Other Identifiers

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1122837

Identifier Type: -

Identifier Source: org_study_id