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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Ministry of Health, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Health, China
ClinicalTrials.gov Identifier:
NCT00685308
First received: May 23, 2008
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention
Intracranial Atherosclerosis
 Procedure: Stenting of atherosclerotic intracranial stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Ministry of Health, China:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 23, 2008
Last Updated: May 27, 2008
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013