NCT01186107

Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Detailed description

Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Conditions

• Coronary Artery Disease
• Diabetes

Interventions

Type	Name	Description
DEVICE	Endeavor Resolute stent	zotarolimus-eluting stent
DEVICE	Cypher stent	sirolimus-eluting stent

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2010-08-23
• Last updated: 2014-07-29

Locations

11 sites across 1 country: South Korea