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Introduction to Clinical Trials
Introduction to Clinical Trials
Review frequently asked questions and introductory information about clinical trials.
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List of Clinical Trials
Open Clinical Trial
A Prospective , Single Blind, Randomized, Multi-Center, Study Comparing the Cypher-ELITE to Cypher Bx VELOCITY Sirolimus-Eluting Stent Systems (ELITE Study).
The ELITE study will evaluate multiple safety and efficacy measures including target lesion revascularization, major adverse cardiac events (MACE) such as death, myocardial infarctions, and stent thrombosis. Additionally, the study population will also allow for analysis on such complex patient groups as diabetics and multi-vessel disease. Additionally, the ELITE study will add to the safety and efficacy data available for drug eluting stents.
Principal Investigator
Pedro R. Moreno
Compensation
N
Inclusion
1.Subjects with coronary artery disease in 1 or 2 blood vessels
2.The subject must be >18 years of age
3.Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
4.Diagnosis of chest pain. 5. Treatment of more than two major coronary arteries. 6.Subject is willing to comply with the specified follow-up evaluation.
Exclusion
1.EKG changes of Myocardial Infarction
2.Prior intervention target blood vessel
3.Left ventricular ejection fraction <25%
4.Impaired renal function
5.Recipient of heart transplant
6.Subject with a life expectancy less than 12 months
7.Allergies to Aspirin, Plavix and Ticlid.
8.Currently participating in an investigational drug or device study
9.Bleeding disorder
10.Subject is either pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
11. Major surgical or interventional procedures within 30 days prior to this study
Research Study Site
Mount Sinai Medical Center
Department Name
MSSM Cardiovascular Institute
Contact Information
Kameswari Vallabhajosyula [Coordinator]
Mrs.
kameswari.vallabhajosyula@msnyuhealth.org
212-241-5696 45696
GCO Number
07-1252
IRB Start/End Date
November 27, 2008 to November 26, 2009
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