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Evaluation of Effectiveness and Safety of NOBORI Stent (IRIS-NOBORI)

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.
ClinicalTrials.gov Identifier: NCT01348360
Recruitment Status : Active, not recruiting
First Posted : May 5, 2011
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

May 4, 2011
May 5, 2011
July 21, 2017
May 2010
May 2016   (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 NCT01348360 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 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 and up to 5 years ]
  • Composite of death or MI [ Time Frame: 6 months ]
  • Composite of 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: one month ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly up to 5 years ]
  • 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: At discharge from the index hospitalization ]
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Evaluation of Effectiveness and Safety of NOBORI Stent
Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study
The objective of this study is to evaluate effectiveness and safety of Nobori stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of NOBORI stents versus first-generation DES in patients with coronary artery disease.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with coronary artery disease requiring drug eluting stents
Coronary Artery Disease
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NOBORI stent
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
April 2020
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving NOBORI stents.
  • 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
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
  • CardioVascular Research Foundation, Korea
  • Terumo Corporation
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
July 2017