Coronary Artery DiseaseNCT01348373
Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 16 sites in South Korea.
Trial summary
The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 464 participants
- Where
- 16 sitesSouth Korea
- Study dates
- May 2010to Jun 2014
- 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: STEMI Patients requiring primary PCI.
Who may be able to join
- STEMI Patients requiring primary PCI.
- 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
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Konyang University Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
National Health Insurance Corporation Ilsan Hospital
Ilsan
Gachon University Gil Hospital
Incheon
Inha University Hospital
Incheon
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Kangbuk Samsung Medical Center
Seoul
SMA-SNU Boramae Medical Center
Seoul
Ulsan University Hospital
Ulsan
Wonju Christian Hospital
Wŏnju
About this study
Official title: Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction
The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).
Read the detailed description
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stents
- 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 |
|---|---|---|
| GENOUS EPC-coated stent | Patients treated with GENOUS EPC-coated stent |
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 death or MI
Measured: 6 months
Composite of death or MI
Measured: yearly up to 5 years
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 up to 5 years
TVR
Measured: one month
TVR
Measured: 6 months
TVR
Measured: yearly up to 5 years
Target-lesion revascularization (TLR)
Measured: yearly up to 5 years
Target-lesion revascularization (TLR)
Measured: one month
Target-lesion revascularization (TLR)
Measured: 6 months
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: in-hospital
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 completionJun 2014
- Study completionJun 2014
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
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, OrbusNeich Medical Korea Co., Ltd.
- 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
- NCT01348373
- Sponsor's protocol ID
- CVRF2010-05
- Status last verified
- Nov 2015
- First submitted
- 4 May 2011
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of the GENOUS STENT in ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01348373
- Acronym / sponsor ID
- CVRF2010-05
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, OrbusNeich Medical Korea Co., Ltd.
- Study start
- May 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (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 GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).
Detailed description
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOUS EPC-coated stent | – | –Patients treated with GENOUS EPC-coated stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- STEMI Patients requiring primary PCI.
Key inclusion criteria (2 listed)
- STEMI Patients requiring primary PCI.
- 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 death or MI
Time frame: 6 months
Composite of death or MI
Time frame: yearly up to 5 years
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 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: yearly up to 5 years
Target-lesion revascularization (TLR)
Time frame: one month
Target-lesion revascularization (TLR)
Time frame: 6 months
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: in-hospital
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 11 Nov 2015.
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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
16 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 16 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 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 11 Nov 2015.