Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Information source: Peking Union Medical College Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Transient Ischemic Attack; Atherosclerosis; Stenosis; Stents
Intervention: Stent implantation (Wingspan, Coroflex, and TiTAN2) (Device); Standard medical treatment (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Peking Union Medical College Hospital Official(s) and/or principal investigator(s):
Liying Cui, Principal Investigator, Affiliation: Peking Union Medical College Hospital
Overall contact:
Liying Cui, Phone: 86-10-65296373, Email: pumchcly@yahoo.com.cn
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 prevention of ischemic stroke.
Clinical Details
Official title: Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Study design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Ischemic stroke in the supply area of stent implantation artery
Secondary outcome: Hemorrhagic strokeIschemic stroke in the supply area of non-stent implantation artery Acute coronary syndrome All-cause death Transient ischemic attack Degree of re-stenosis of the stent implantation artery
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Aged between above 40 year-old and 75 year-old.
2. Ischemic stroke related to extra- and intracranial atherosclerosis stenosis,
transient ischemic attack (TIA ), onset time within 90 days
3. Implantation of stent should be at least 1 week after stroke onset, and patient's
medical condition stable, no time limit for TIA,
4. Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
5. Degree of stenosis of target artery ranges between 51%-99%
6. Modified Rankin score≤3 or NIHSS Score ≤4
7. Informed consent is obtained.
Exclusion Criteria:
Patients will be excluded from entry if any of the criteria listed below are met:
1. Target stenosis artery is not suitable for stent implantation after evaluation.
2. Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent
implantation.
3. Ischemic stroke is caused by conditions other than atherosclerosis .
4. Documented non-atherosclerosis angiopathy.
5. Clinically unstable at the time of enrollment,
6. Conditions which may lead to cardiogenic embolism : arterial fibrillation，left
ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
7. Severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure
>110 mmHg)
8. 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
9. Significant memory or behavioral disorder, ie, Alzheimer disease, etc. daily care
needed.
10. Concurrent participation in another clinical trial
11. Unable to return follow up
12. History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic
Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
13. Intracranial arteriovenous malformation or aneurysm.
Locations and Contacts
Liying Cui, Phone: 86-10-65296373, Email: pumchcly@yahoo.com.cn
Xuanwu Hospital Capital Medical University, Beijing 100053, China; Recruiting
Zhongrong Miu, Phone: 86-13601243293
Beijing Tiantan Hospital, Beijing 100050, China; Recruiting
Weijian Jiang
Peking Union Medical College Hospital, Beijing 100730, China; Recruiting
Zhengyu Jin, Phone: 65295441
Daping Hospital, Chongqing 400042, China; Recruiting
Huadong Zhou, Email: zhouhuad@163.com
Southwest Hospital, Chongqing 400038, China; Recruiting
Shugui Shi, Email: southwestneuro@163.com
Huashan Hospital Fudan University, Shanghai 200040, China; Recruiting
Liang Wang, Email: autum88_cn@yahoo.com
the General Hospital Under Tianjin Medical Sciences University, Tianjin 300052, China; Recruiting
Yan Cheng, Email: cylfl@sohu.com
Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu 210002, China; Recruiting
Gelin Xu, Email: gelinxu@gmail.com
Jilin University, Changchun, Jilin 130021, China; Recruiting
Jiang Wu, Email: sjnwujiang@sina.com
West China Center of Medical Sciences, Chengdu, Sichuan 610041, China; Recruiting
Dong Zhou, Email: zhoudong66@yahoo.de
Additional Information
Starting date: June 2008
Ending date: August 2010
Last updated: September 17, 2009
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