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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00685308
Other study ID # 1122837
Secondary ID
Status Recruiting
Phase N/A
First received May 23, 2008
Last updated May 27, 2008
Start date December 2007
Est. completion date October 2010

Study information

Verified date May 2008
Source Ministry of Health, China
Contact Wei-Jian Jiang, MD
Phone 86-10-6706-1935
Email cjr.jiangweijian@vip.163.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
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%.

Locations

Country Name City State
China Beijiang Tiantan Hospital, The Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year One year No
Secondary Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis. One year No
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