Coronary Artery DiseaseNCT01348399
Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 29 sites in South Korea.
Trial summary
The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared 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
- 2,000 participants
- Where
- 29 sitesSouth Korea
- Study dates
- Apr 2011to Sep 2017
- 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 receiving XIENCE PRIME stents.
Who may be able to join
- Patients receiving XIENCE PRIME 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 presented with cardiogenic shock
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
South Korea29 sites
Hallym University Sacred Heart Hospital
Anyang
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
National Health Insurance Corporation Ilsan Hospital
Ilsan
Presbyterian Medical Center
Jeonju
Gyeongsang National University Hospital
Jinju
Kwangju Christian Hospital
Kwangju
Inje University Pusan Paik Hospital
Pusan
Pusan National University Hospital
Pusan
Pusan National University Yangsan Hospital
Pusan
Bundang Cha Medical Center
Seongnam
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Kangnam Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyunghee University Hospital at Gangdong
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
St.carollo Hospital
Suncheon
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 XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)
Read the detailed description
This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease requiring 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 |
|---|---|---|
| XIENCE PRIME stents | 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 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: 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 startApr 2011
- Primary completionJul 2014
- Study completionSep 2017
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, Abbott
- 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
- NCT01348399
- Sponsor's protocol ID
- CVRF2011-01
- Status last verified
- Jun 2018
- First submitted
- 4 May 2011
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01348399
- Acronym / sponsor ID
- CVRF2011-01
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease requiring drug eluting stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Abbott
- Study start
- Apr 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2017 (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 XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)
Detailed description
This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIME stents | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving XIENCE PRIME stents.
Key inclusion criteria (2 listed)
- Patients receiving XIENCE PRIME 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 presented 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 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: 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 20 Jun 2018.
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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
29 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 29 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 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 20 Jun 2018.