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| Sponsor: | Peking Union Medical College Hospital |
|---|---|
| Information provided by: | Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT00691314 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke Transient Ischemic Attack Atherosclerosis Stenosis Stents |
Device: Stent implantation (Wingspan, Coroflex, and TiTAN2) Drug: Standard medical treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
Stent Implantation: Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex® - 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 |
| Active Comparator: 2 |
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)
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from entry if any of the criteria listed below are met:
Contacts and Locations| China, Beijing | |
| Xuanwu Hospital Capital Medical University | |
| Beijing, Beijing, China, 100053 | |
| Beijing Tiantan Hospital | |
| Beijing, Beijing, China, 100050 | |
| Peking Union Medical College Hospital | |
| Beijing, Beijing, China, 100730 | |
| China, Chongqing | |
| Daping Hospital | |
| Chongqing, Chongqing, China, 400042 | |
| Southwest Hospital | |
| Chongqing, Chongqing, China, 400038 | |
| China, Jiangsu | |
| Nanjing General Hospital of Nanjing Military Command | |
| Nanjing, Jiangsu, China, 210002 | |
| China, Jilin | |
| Jilin University | |
| Changchun, Jilin, China, 130021 | |
| China, Shanghai | |
| Huashan Hospital Fudan University | |
| Shanghai, Shanghai, China, 200040 | |
| China, Sichuan | |
| West China Center of Medical Sciences | |
| Chengdu, Sichuan, China, 610041 | |
| China, Tianjin | |
| The General Hospital Under Tianjin Medical Sciences University | |
| Tianjin, Tianjin, China, 300052 | |
| Principal Investigator: | Liying Cui | Peking Union Medical College Hospital |
More Information
| Responsible Party: | Liying Cui, Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT00691314 History of Changes |
| Other Study ID Numbers: | 2006BAI01A10-2 |
| Study First Received: | April 12, 2008 |
| Last Updated: | February 23, 2011 |
| Health Authority: | China: Ministry of Health |
|
Stroke Transietn Ischemic Attack Stents Stenosis |
|
Atherosclerosis Ischemic Attack, Transient Constriction, Pathologic Ischemia Stroke Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathological Conditions, Anatomical Pathologic Processes |