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

Information source: Peking Union Medical College Hospital
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: Peking Union Medical College Hospital

Official(s) and/or principal investigator(s):
Liying Cui, Principal Investigator, Affiliation: Peking Union Medical College Hospital


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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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.


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

Beijing Tiantan Hospital, Beijing, Beijing 100050, China

Peking Union Medical College Hospital, Beijing, Beijing 100730, China

Xuanwu Hospital Capital Medical University, Beijing, Beijing 100053, China

Daping Hospital, Chongqing, Chongqing 400042, China

Southwest Hospital, Chongqing, Chongqing 400038, China

Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu 210002, China

Jilin University, Changchun, Jilin 130021, China

Huashan Hospital Fudan University, Shanghai, Shanghai 200040, China

West China Center of Medical Sciences, Chengdu, Sichuan 610041, China

The General Hospital Under Tianjin Medical Sciences University, Tianjin, Tianjin 300052, China

Additional Information

Starting date: June 2008
Last updated: February 23, 2011

Page last updated: August 23, 2015

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