Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
- Conditions
- StenosisStentsStrokeTransient Ischemic AttackAtherosclerosis
- Interventions
- Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)Drug: Standard medical treatment
- Registration Number
- NCT00691314
- Lead Sponsor
- Peking Union Medical College Hospital
- 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 prevention of ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Stent implantation (Wingspan, Coroflex, and TiTAN2) - 2 Standard medical treatment -
- Primary Outcome Measures
Name Time Method Ischemic stroke in the supply area of stent implantation artery 30 days and 1 year after the procedure
- Secondary Outcome Measures
Name Time Method All-cause death 30 days and 1 year after the procedure Acute coronary syndrome 30 days and 1 year after the procedure Ischemic stroke in the supply area of non-stent implantation artery 30 days and 1 year after the procedure Hemorrhagic stroke 30 days and 1 year after the procedure Transient ischemic attack 30 days and 1 year after the procedure Degree of re-stenosis of the stent implantation artery 30 days and 1 year after the procedure
Trial Locations
- Locations (10)
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Nanjing General Hospital of Nanjing Military Command
🇨🇳Nanjing, Jiangsu, China
Jilin University
🇨🇳Changchun, Jilin, China
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Southwest Hospital
🇨🇳Chongqing, Chongqing, China
Daping Hospital
🇨🇳Chongqing, Chongqing, China
West China Center of Medical Sciences
🇨🇳Chengdu, Sichuan, China
The General Hospital Under Tianjin Medical Sciences University
🇨🇳Tianjin, Tianjin, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China