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

This study is currently recruiting participants.
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
  Purpose

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).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study

Resource links provided by NLM:


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 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 ]

Estimated Enrollment: 2000
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
NOBORI stent

Detailed Description:

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.

  Eligibility

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

Patients with coronary artery disease requiring drug eluting stents

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348360

Contacts
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

Locations
Korea, Republic of
26 Centers Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Duk-Woo Park
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: Duk-Woo Park, MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01348360     History of Changes
Other Study ID Numbers: CVRF2010-02
Study First Received: May 4, 2011
Last Updated: April 26, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014