Status:
COMPLETED
Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Stroke
Transient Ischemic Attack
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary preve...
Eligibility Criteria
Inclusion
- Aged between above 40 year-old and 75 year-old.
- Ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (TIA ), onset time within 90 days
- Implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for TIA,
- Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
- Degree of stenosis of target artery ranges between 51%-99%
- Modified Rankin score≤3 or NIHSS Score ≤4
- Informed consent is obtained.
Exclusion
- Patients will be excluded from entry if any of the criteria listed below are met:
- Target stenosis artery is not suitable for stent implantation after evaluation.
- Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
- Ischemic stroke is caused by conditions other than atherosclerosis .
- Documented non-atherosclerosis angiopathy.
- Clinically unstable at the time of enrollment,
- Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
- Severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
- Severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years
- Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.
- Concurrent participation in another clinical trial
- Unable to return follow up
- History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
- Intracranial arteriovenous malformation or aneurysm.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00691314
Start Date
June 1 2008
End Date
December 1 2010
Last Update
February 24 2011
Active Locations (10)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
2
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038