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

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ClinicalTrials.gov Identifier: NCT00685308
Recruitment Status : Unknown
Verified May 2008 by Ministry of Health, China.
Recruitment status was:  Recruiting
First Posted : May 28, 2008
Last Update Posted : May 28, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Intracranial Atherosclerosis 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 Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
Study Start Date : December 2007
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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%.

    Other Name: Wingspan stenting for intracranial stenosis

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese population with symptomatic severe stenosis of intracranial atherosclerosis
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685308


Contacts
Contact: Wei-Jian Jiang, MD 86-10-6706-1935 cjr.jiangweijian@vip.163.com

Locations
China
Beijiang Tiantan Hospital, The Capital Medical University Recruiting
Beijing, China, 100050
Sponsors and Collaborators
Ministry of Health, China
Investigators
Principal Investigator: Wei-Jian Jiang, MD Beijing Tiantan Hospital, The Capital Medical University, Beijing, China
More Information

Responsible Party: Wei-Jian Jiang /Chairman of Interventional Neuroradiology, Beijing Tiantan Hospital, The Capital Medical University (CMU)
ClinicalTrials.gov Identifier: NCT00685308     History of Changes
Other Study ID Numbers: 1122837
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by Ministry of Health, China:
Atherosclerosis
Intracranial artery
Angioplasty
Stent

Additional relevant MeSH terms:
Atherosclerosis
Intracranial Arteriosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases