China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China
The primary objective is to document the acute and mid-term safety and overall clinical performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a "real world" Chinese patient population requiring stent implantation.
To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor™ Zotarolimus Eluting Coronary Stent System in Chinese Patients, A Prospective, Multicenter Registry|
- MACE [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
The safety and efficacy of the Endeavor(TM) Zotarolimus Eluting Coronary Stent System has been assessed in a series of studies, e.g. ENDEAVOR I and ENDEAVOR II. The stent is composed of a cobalt alloy and is coated with a proprietary drug compound zotarolimus that is designed to reduce restenosis.
This registry with the Endeavor(TM) Zotarolimus Eluting Coronary Stent System is being initiated 1) to expand the clinical knowledge base by including 'real world'patients in China and 2) to assess the event rate in Chinese patients known to have a higher risk of major adverse cardiac events, for example patients with diabetes mellitus, small vessels and long lesions.
In total the plan is to enroll about 2200 patients from 37 sites.
Follow-up will be one year for the main patients with cohort to collect acute and mid-term follow-up data, but will be extended to two years for certain patient subgroups.
|Principal Investigator:||Jiyan Chen, Professor||Guangdong Provincial People's Hospital|
|Principal Investigator:||Yaling Han, Professor||Shenyang North Hospital|
|Principal Investigator:||Yong Huo, Professor||Peking University First Hospital|
|Principal Investigator:||Weimin Wang, Professor||Beijing People's Hospital|
|Principal Investigator:||Bo Xu, Director||Beijing Fuwai Hospital|