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

May 27, 2008 updated by: Ministry of Health, China

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.

Study Overview

Status

Unknown

Conditions

Intracranial Atherosclerosis

Intervention / Treatment

Procedure: Stenting of atherosclerotic 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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China, 100050
    - Recruiting
    - Beijiang Tiantan Hospital, The Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese population with symptomatic severe stenosis of intracranial atherosclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
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	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, China

Investigators

Principal Investigator: Wei-Jian Jiang, MD, Beijing Tiantan Hospital, The Capital Medical University, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)