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:
Duk-Woo Park
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
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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 June 18, 2013