NCT00685308

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Ministry of Health, China · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-10-01
• Completion: 2010-10-01
• First posted: 2008-05-28
• Last updated: 2008-05-28

Locations

1 site across 1 country: China