Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

Seoul National University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Endeavor Sprint stent; Device: Endeavor Resolute stents

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00960908

RESOLUTE-KOREA

Details and patient eligibility

About

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.

The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).

Enrollment: 4,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient agrees to participate in this study by signing the informed consent form.
• Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion criteria

• There are no exclusion criteria for this registry.

Trial design

4,000 participants in 2 patient groups

Resolute

Description:

Prospective recruitment of Resolute arm will start in March 2009

Treatment:

Device: Endeavor Resolute stents

Endeavor

Description:

The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study.

Treatment:

Device: Endeavor Sprint stent