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

May 23, 2008
May 27, 2008
December 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00685308 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Chinese population with symptomatic severe stenosis of intracranial atherosclerosis

Intracranial Atherosclerosis
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2010
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Wei-Jian Jiang, MD 86-10-6706-1935 cjr.jiangweijian@vip.163.com
China
 
NCT00685308
1122837
Yes
Wei-Jian Jiang /Chairman of Interventional Neuroradiology, Beijing Tiantan Hospital, The Capital Medical University (CMU)
Ministry of Health, China
Not Provided
Principal Investigator: Wei-Jian Jiang, MD Beijing Tiantan Hospital, The Capital Medical University, Beijing, China
Ministry of Health, China
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP