NCT00793312

China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China

To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor™ Zotarolimus Eluting Coronary Stent System in Chinese Patients, A Prospective, Multicenter Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,210 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-09-01
• Completion: 2010-09-01
• First posted: 2008-11-19
• Last updated: 2012-10-17