Status:
UNKNOWN
Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
Lead Sponsor:
Ministry of Health, China
Conditions:
Intracranial Atherosclerosis
Eligibility:
All Genders
18-75 years
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 s...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00685308
Start Date
December 1 2007
End Date
October 1 2010
Last Update
May 28 2008
Active Locations (1)
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1
Beijiang Tiantan Hospital, The Capital Medical University
Beijing, China, 100050