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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348373
First Posted: May 5, 2011
Last Update Posted: November 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CardioVascular Research Foundation, Korea
OrbusNeich Medical Korea Co., Ltd.
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
May 4, 2011
May 5, 2011
November 11, 2015
May 2010
June 2014   (Final data collection date for primary outcome measure)
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ]
Same as current
Complete list of historical versions of study NCT01348373 on ClinicalTrials.gov Archive Site
  • Death (all cause and cardiac) [ Time Frame: one month ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ]
  • Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ]
  • MI [ Time Frame: one month ]
  • MI [ Time Frame: 6 months ]
  • MI [ Time Frame: yearly up to 5 years ]
  • Composite of death or MI [ Time Frame: one month ]
  • Composite of death or MI [ Time Frame: 6 months ]
  • Composite of death or MI [ Time Frame: yearly up to 5 years ]
  • Composite of cardiac death or MI [ Time Frame: one month ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ]
  • Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ]
  • TVR [ Time Frame: one month ]
  • TVR [ Time Frame: 6 months ]
  • TVR [ Time Frame: yearly up to 5 years ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly up to 5 years ]
  • Target-lesion revascularization (TLR) [ Time Frame: one month ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 6 months ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 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) [ Time Frame: in-hospital ]
Not Provided
Not Provided
Not Provided
 
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).
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
STEMI Patients requiring primary PCI.
Coronary Artery Disease
Not Provided
GENOUS EPC-coated stent
Patients treated with GENOUS EPC-coated stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
464
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01348373
CVRF2010-05
Yes
Not Provided
Not Provided
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
  • CardioVascular Research Foundation, Korea
  • OrbusNeich Medical Korea Co., Ltd.
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
CardioVascular Research Foundation, Korea
November 2015