Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

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

The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic excra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.

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 stroke

Ischemic 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

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 30 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 enrolment,

6. Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardic 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 behavioural 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 Thrornbocytopenic Purpura,etc ) or bleeding tendency conditions.

13. Intracranial arteriovenous malformation or aneurysm.

Liying Cui, Phone: 86-10-65296373, Email: pumchcly@yahoo.com.cn

Xuanwu Hospital Capital Medical University, Beijing 100053, China; Not yet recruiting
Zhongrong Miu, Phone: 86-13601243293

Beijing Tiantan Hospital, Beijing 100050, China; Not yet recruiting
Weijian Jiang

Peking Union Medical College Hospital, Beijing 100730, China; Recruiting
Zhengyu Jin, Phone: 65295441

Daping Hospital, Chongqing 400042, China; Not yet recruiting
Huadong Zhou, Email: zhouhuad@163.com

Southwest Hospital, Chongqing 400038, China; Not yet recruiting
Shugui Shi, Email: southwestneuro@163.com

Huashan Hospital Fudan University, Shanghai 200040, China; Not yet recruiting
Liang Wang, Email: autum88_cn@yahoo.com

the General Hospital Under Tianjin Medical Sciences University, Tianjin 300052, China; Not yet recruiting
Yan Cheng, Email: cylfl@sohu.com

Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu 210002, China; Not yet recruiting
Gelin Xu, Email: gelinxu@gmail.com

Jilin University, Changchun, Jilin 130021, China; Not yet recruiting
Jiang Wu, Email: sjnwujiang@sina.com

West China Center of Medical Sciences, Chengdu, Sichuan 610041, China; Not yet recruiting
Dong Zhou, Email: zhoudong66@yahoo.de

Starting date: June 2008
Ending date: August 2010
Last updated: June 17, 2008