NCT01515228

Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: CHEOL WHAN LEE, MD, PhD. · Academic / Other
• Sex: All
• Age: 21 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Detailed description

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 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) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Xience Prime	everolimus-eluting stent implantation
DEVICE	Cilotax stent	paclitaxel with cilostazol dual drug eluting stent implantation

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2012-01-24
• Last updated: 2015-01-09

Locations

9 sites across 1 country: South Korea