A Study to Evaluate Safety and Efficacy of the ExcelTM Sirolimus Eluting Stent With a Biodegradable Polymer Versus Sirolimus Eluting Stent With Non-Biodegradable Polymer in the Treatment of Patients With de Novo Coronary Artery Lesions

PHASE4UnknownINTERVENTIONAL
Enrollment

1,944

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2014

Conditions
IschemiaCardiac DeathMyocardial Infarction
Interventions
DEVICE

Percutaneous Transluminal Coronary Angioplasty

Patients will be randomly assigned (2:1) to one of two treatment arms (the Excel DES or the Cypher DES). Randomization will be stratified by study site and number of vessels intended to be treated by the site investigator. Randomization will be accomplished through use of envelope randomization at the sites using the pre-assigned envelope randomization system. The study patient is considered enrolled upon randomization.

Trial Locations (1)

100037

RECRUITING

JW Medical Systems, Beijing

Sponsors
All Listed Sponsors
lead

JW Medical Systems Ltd

INDUSTRY