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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief 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 Summary:

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.

Sponsor: Ministry of Health, China

Current Primary Outcome: Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: One year ]

Original Secondary Outcome: Same as current

Information By: Ministry of Health, China

Dates:
Date Received: May 23, 2008
Date Started: December 2007
Date Completion: October 2010
Last Updated: May 27, 2008
Last Verified: May 2008