Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)

Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction

The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.

• Study Type: Observational
• Enrollment (Actual): 464

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Chuncheon, Korea, Republic of
    • KangWon National University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Konyang University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Medical Center
  • Seoul, Korea, Republic of
    • SMA-SNU Boramae Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

STEMI Patients requiring primary PCI.

Description

Inclusion Criteria:

• STEMI Patients requiring primary PCI.
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

• Patients with a mixture of other DESs
• Terminal illness with life expectancy <1 year
• Patients with cardiogenic shock

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GENOUS EPC-coated stent; Patients treated with GENOUS EPC-coated stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Death (all cause and cardiac)	6 months
Death (all cause and cardiac)	yearly up to 5 years
Composite of death or MI	6 months
Composite of death or MI	yearly up to 5 years
Composite of cardiac death or MI	6 months
Composite of cardiac death or MI	yearly up to 5 years
Composite of death or MI	one month
Composite of cardiac death or MI	one month
MI	one month
MI	6 months
TVR	one month
TVR	6 months
Target-lesion revascularization (TLR)	one month
Target-lesion revascularization (TLR)	6 months
Stent thrombosis (ARC criteria)	one month
Stent thrombosis (ARC criteria)	6 months
Death (all cause and cardiac)	one month
MI	yearly up to 5 years
TVR	yearly up to 5 years
Target-lesion revascularization (TLR)	yearly up to 5 years
Stent thrombosis (ARC criteria)	yearly up to 5 years
Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)	in-hospital

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea; OrbusNeich Medical Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: drug eluting stents
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CVRF2010-05