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| Sponsor: | Beijing Chao Yang Hospital |
|---|---|
| Information provided by: | Beijing Chao Yang Hospital |
| ClinicalTrials.gov Identifier: | NCT00781716 |
Purpose
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction Coronary Artery Disease |
Device: Drug eluting coronary stent system |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Safety and Efficacy of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction and Analysis of Current Status of Emergency PCI Green Channel for Patients With ST Elevation Myocardial Infarction in China |
| Estimated Enrollment: | 1020 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cypher Stent
Cypher Sirolimus-Eluting Coronary Stent System
|
Device: Drug eluting coronary stent system
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
|
|
Active Comparator: Endeavor Stent
Endeavor Zotarolimus-Eluting Coronary Stent System
|
Device: Drug eluting coronary stent system
Cypher Sirolimus-Eluting Coronary Stent System vs Endeavor Zotarolimus-Eluting Coronary Stent System
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: LeFeng Wang, MD | 86-13601255020 | CrestMI@gmail.com |
| Contact: Caihong Wang | 86-13001980897 | crest_mi@sina.com |
| China, BJ | |
| Beijing Chaoyang Hospital Heart Center | Not yet recruiting |
| Beijing, BJ, China, 10000 | |
| Contact: LeFeng Wang, MD 86-13601255020 CrestMI@gmail.com | |
| Principal Investigator: | LeFeng Wang, MD | Chaoyang Hospital |
More Information
| Responsible Party: | Dr. LeFeng Wang/Director of the Cath Lab, Beijing Chao Yang Hospital Heart Center |
| ClinicalTrials.gov Identifier: | NCT00781716 History of Changes |
| Other Study ID Numbers: | Version 1.0-Sep 10, 2008 |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 28, 2008 |
| Health Authority: | China: State Food and Drug Administration |
|
ST elevation myocardial infarction Drug eluting stents |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Emergencies Infarction Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Disease Attributes Pathologic Processes Ischemia |
Necrosis Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |