Coronary Artery DiseaseIRIS-NOBORINCT01348360
Evaluation of Effectiveness and Safety of NOBORI Stent
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 26 sites in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,000 participants
- Where
- 26 sitesSouth Korea
- Study dates
- May 2010to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary artery disease requiring drug eluting stents
Who may be able to join
- 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.
Who cannot join
- Patients with a mixture of other DESs.
- Terminal illness with life expectancy <1 year.
- Patients with cardiogenic shock.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
The Catholic University of Korea, Bucheon ST.Mary's Hospital
Bucheon-si
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Asan Medical Center
Gangneung
Chonnam National University Hospital
Gwangju
DongGuk University Gyongju Hospital
Gyeongju
National Health Insurance Corporation Ilsan Hospital
Ilsan
Gachon University Gil Hospital
Incheon
Inha University Hospital
Incheon
Chonbuk National University Hospital
Jeonju
Kwangju Christian Hospital
Kwangju
Asan Medical Center
Seoul, Republic of Korea, 138-736
KangBuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
Korea University Hospital
Seoul
Kyung Hee University Medical Hospital
Seoul
St. Mary's Catholic Medical Center
Seoul
The Catholic University of Korea St.Paul's Hospital
Seoul
The Catholic University of Korea Yeouido St.Mary's Hospital
Seoul
The Catholic University of Korea St. Vincent's Hospital
Suwon
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si
Ulsan University Hospital
Ulsan
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOBORI stent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Measured: 12 months post procedure
Secondary outcomes (22)
Death (all cause and cardiac)
Measured: one month
Death (all cause and cardiac)
Measured: 6 months
Death (all cause and cardiac)
Measured: yearly up to 5 years
MI
Measured: one month
MI
Measured: 6 months
MI
Measured: yearly up to 5 years
Composite of death or MI
Measured: one month
Composite of cardiac death or MI
Measured: one month
Composite of cardiac death or MI
Measured: 6 months
Composite of cardiac death or MI
Measured: yearly and up to 5 years
Composite of death or MI
Measured: 6 months
Composite of death or MI
Measured: yearly up to 5 years
TVR
Measured: one month
TVR
Measured: 6 months
TVR
Measured: yearly up to 5 years
Target-lesion revascularization (TLR)
Measured: one month
Target-lesion revascularization (TLR)
Measured: 6 months
Target-lesion revascularization (TLR)
Measured: yearly up to 5 years
Stent thrombosis (ARC criteria)
Measured: one month
Stent thrombosis (ARC criteria)
Measured: 6 months
Stent thrombosis (ARC criteria)
Measured: 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)
Measured: At discharge from the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Terumo Corporation
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical CenterKi Bae Seung, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348360
- Sponsor's protocol ID
- CVRF2010-02
- Acronym
- IRIS-NOBORI
- Status last verified
- Jan 2020
- First submitted
- 4 May 2011
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT01348360
- Acronym / sponsor ID
- IRIS-NOBORI / CVRF2010-02
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Terumo Corporation
- Study start
- May 2010 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOBORI stent | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary artery disease requiring drug eluting stents
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with a mixture of other DESs.
- Terminal illness with life expectancy <1 year.
- Patients with cardiogenic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time frame: 12 months post procedure
22 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
Ki Bae Seung, MD, PhD principal investigator
Seoul St. Mary's Hospital, Catholic University of Korea
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 26 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.