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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01348373
First received: May 4, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all cause and cardiac) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: one month ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: in-hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
GENOUS EPC-coated stent
Patients treated with GENOUS EPC-coated stent

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

STEMI Patients requiring primary PCI.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348373

Locations
Korea, Republic of
24 Centers Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD, PhD     82-2-3010-4812     sjpark@amc.seoul.kr    
Contact: Duk-Woo Park, MD, PhD     82-2-3010-3995     dwpark@amc.seoul.kr    
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
Principal Investigator: Ki Bae Seung, MD, PhD Seoul St. Mary's Hospital, Catholic University of Korea
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01348373     History of Changes
Other Study ID Numbers: CVRF2010-05
Study First Received: May 4, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:
drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013