Clinical trial NCT01348373: Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)
Official title: Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: OrbusNeich Medical Korea Co., Ltd.
First posted: 2011-05-05
Enrollment: 464
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI Patients requiring primary PCI.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Death (all cause and cardiac)
timeFrame: one month
measure: Death (all cause and cardiac)
timeFrame: 6 months
measure: Death (all cause and cardiac)
timeFrame: yearly up to 5 years
measure: MI
timeFrame: one month
measure: MI
timeFrame: 6 months
measure: MI
timeFrame: yearly up to 5 years
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: yearly up to 5 years
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: yearly up to 5 years
measure: TVR
timeFrame: one month
measure: TVR
timeFrame: 6 months
measure: TVR
timeFrame: yearly up to 5 years
measure: Target-lesion revascularization (TLR)
timeFrame: yearly up to 5 years
measure: Target-lesion revascularization (TLR)
timeFrame: one month
measure: Target-lesion revascularization (TLR)
timeFrame: 6 months
measure: Stent thrombosis (ARC criteria)
timeFrame: one month
measure: Stent thrombosis (ARC criteria)
timeFrame: 6 months
measure: Stent thrombosis (ARC criteria)
timeFrame: yearly up to 5 years
measure: 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)
timeFrame: in-hospital
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMA-SNU Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, Catholic University of Korea
name: Ki Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: