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

• Conditions: Intracranial Atherosclerosis

• Registration Number: NCT00685308
• Lead Sponsor: Ministry of Health, 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 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.

Study Timeline

• Study Start: 2007-12
• Status Verified: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Last Update Submitted: 2008-05-27
• Study First Posted: 2008-05-28
• Last Update Posted: 2008-05-28
• Primary Completion: 2009-10
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year	One year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijiang Tiantan Hospital, The Capital Medical University; 🇨🇳 Beijing, China