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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348373
• Other study ID #: CVRF2010-05
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: November 10, 2015
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea, OrbusNeich Medical Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)		12 months post procedure	Yes
Secondary	Death (all cause and cardiac)		one month	Yes
Secondary	Death (all cause and cardiac)		6 months	Yes
Secondary	Death (all cause and cardiac)		yearly up to 5 years	Yes
Secondary	MI		one month	Yes
Secondary	MI		6 months	Yes
Secondary	MI		yearly up to 5 years	Yes
Secondary	Composite of death or MI		one month	Yes
Secondary	Composite of death or MI		6 months	Yes
Secondary	Composite of death or MI		yearly up to 5 years	Yes
Secondary	Composite of cardiac death or MI		one month	Yes
Secondary	Composite of cardiac death or MI		6 months	Yes
Secondary	Composite of cardiac death or MI		yearly up to 5 years	Yes
Secondary	TVR		one month	No
Secondary	TVR		6 months	No
Secondary	TVR		yearly up to 5 years	No
Secondary	Target-lesion revascularization (TLR)		yearly up to 5 years	No
Secondary	Target-lesion revascularization (TLR)		one month	No
Secondary	Target-lesion revascularization (TLR)		6 months	No
Secondary	Stent thrombosis (ARC criteria)		one month	Yes
Secondary	Stent thrombosis (ARC criteria)		6 months	Yes
Secondary	Stent thrombosis (ARC criteria)		yearly up to 5 years	Yes
Secondary	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	No