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

Intracranial Atherosclerosis Clinical Trial

— WingspanSSIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00685308
• Other study ID #: 1122837
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

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

External Links

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