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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Transient Ischemic Attack, Atherosclerosis, Stenosis, Stents

Intervention / Treatment
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* Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
* Drug: Standard medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)<br>* Stent Implantation: Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stent system and Coroflex Blue - Coronary Stent System; TiTAN2 Bio-active coating stent Standard Medical Management:including antiplatelet agents(Aspirin 75 150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) . Arms: 1<br>|
| Active Comparator: 2<br> | Drug: Standard medical treatment<br>* Standard Medical Management:including antiplatelet agents(Aspirin 75 150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke in the supply area of stent implantation artery |  | 30 days and 1 year after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic stroke |  | 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 | 
| Acute coronary syndrome |  | 30 days and 1 year after the procedure | 
| All-cause death |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Transietn Ischemic Attack, Stents, Stenosis