Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent

Summary

The purpose of this multicenter, randomized, open label, parallel arm study whether the newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9 months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart disease will be enrolled to this "all-comers" trial to give definite answer to the above hypothesis that is urgently needed.

Conditions

• Coronary Artery Disease
• Coronary Heart Disease
• Stable Angina
• Unstable Angina
• ST-segment Elevation Myocardial Infarction
• Non-ST-segment Elevation Myocardial Infarction

Interventions

DEVICE

Osiro Hybrid Drug-Eluting Stent

Osiro Hybrid Drug-Eluting Stent (Biotronik AG, Bulach, Switzeland)

DEVICE

Resolute Integrity

Resolute Integrity zotarolimus-eluting stent (Medtronic Cardiovascular, CA, Minnesota, USA)

Sponsors & Collaborators

• Jeju National University Hospital

  collaborator OTHER

• Chungbuk National University Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Korea University

  collaborator OTHER

• Inje University

  collaborator OTHER

• Kyung Hee University Hospital at Gangdong

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  lead OTHER

Principal Investigators

• Tae-Jin Youn, MD,PhD · Division of Cardiology, Department of Internal Medicine, College of Medicine, Seoul National University and Cardiovascular Center, Seoul National University Bundang Hospital

• Dong-Ju Choi, MD,PhD · Division of Cardiology, Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital

• In-Ho Chae, MD,PhD · Division of Cardiology, Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• South Korea

Study Locations