COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease — COPERES  

Angioplasty, Balloon, Coronary Clinical Trial

Official title: Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients

Status Recruiting

Clinical Trial Summary

The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Balloon, Coronary

• NCT number: NCT01752127
• Study type: Interventional
• Source: Chonbuk National University Hospital
• Contact: Lae young Jung, fellow
• Phone: 82-63-250-2204
• Email: youngjoin@naver.com
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2011
• Completion date: July 2013