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

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.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

• Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
  • Stent Implantation: Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stentsystem 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
• Drug: Standard medical treatment
  • 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, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Ischemic stroke in the supply area of stent implantation artery
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes

Secondary Measures

• Hemorrhagic stroke
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes
• Ischemic stroke in the supply area of non-stent implantation artery
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes
• Acute coronary syndrome
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes
• All-cause death
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes
• Transient ischemic attack
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes
• Degree of re-stenosis of the stent implantation artery
  • Time Frame: 30 days and 1 year after the procedure
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Peking Union Medical College Hospital

Overall Clinical Trial Officials and Contacts

Liying Cui Principal Investigator Peking Union Medical College Hospital  

Overall Contact: Liying Cui 86-10-65296373 pumchcly@yahoo.com.cn

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691314

Study ID Number: 2006BAI01A10-2

ClinicalTrials.gov Identifier: NCT00691314

Health Authority: China: Ministry of Health