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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Information provided by (Responsible Party):
Duk-Woo Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01348360
First received: May 4, 2011
Last updated: April 26, 2012
Last verified: April 2012

May 4, 2011
April 26, 2012
May 2010
December 2012   (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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 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 and up to 5 years ] [ 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 ]
  • 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: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly up to 5 years ] [ 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: At discharge from the index hospitalization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with coronary artery disease requiring drug eluting stents

Coronary Artery Disease
Not Provided
NOBORI stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2016
December 2012   (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.
Both
Not Provided
No
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
Korea, Republic of
 
NCT01348360
CVRF2010-02
Yes
Duk-Woo Park, CardioVascular Research Foundation, Korea
Duk-Woo Park
Not Provided
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
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP