NCT01752127

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Chonbuk National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angioplasty, Balloon, Coronary

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention using drug eluting stent	1\. Intracoronary stenting 1. The procedure could be conducted via brachial, radial or femoral approaches. 2. There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used. 3. When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed. 4. Direct stenting or bifurcation stenting is allowed. 5. Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-12-19
• Last updated: 2012-12-19

Locations

1 site across 1 country: South Korea