Coronary Artery DiseaseNCT01350869
Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Xience
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.
Who may be able to join
- Patients received XIENCE 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
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).
Read the detailed description
This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Xience
- 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.
XienceDevice
Patients with Xience
| Study group | Role | What they receive |
|---|---|---|
| Xience stent | Real world patients treated with XIENCE stents Receives: Device: Xience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.
Measured: at 12 months after PCI
Secondary outcomes (9)
All Death
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Cardiac death
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of death or MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of cardiac death or MI
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
TVR
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Target-lesion revascularization (TLR)
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Stent thrombosis (ARC criteria)
1month ,6 month and 12 months,2year,3year,4 year and 5year
Measured: 1month ,6 month and 12 months,2year,3year,4 year and 5year
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2008
- Primary completionDec 2011
- 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
- 3,000 participants (estimated)
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 Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350869
- Sponsor's protocol ID
- 2009-0588
- Status last verified
- Nov 2015
- First submitted
- 22 Apr 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 Everolimus-Eluting Stents in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01350869
- Acronym / sponsor ID
- 2009-0588
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Abbott
- Study start
- Jun 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 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 everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).
Detailed description
This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xience stent | – | Device: XienceReal world patients treated with XIENCE stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.
Key inclusion criteria (2 listed)
- Patients received XIENCE 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XiencePatients with Xience | Device | Xience stent |
Primary outcome
Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
Time frame: at 12 months after PCI
composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.
9 secondary outcomes
All Death
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Cardiac death
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
MI
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of death or MI
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Composite of cardiac death or MI
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
TVR
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Target-lesion revascularization (TLR)
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Stent thrombosis (ARC criteria)
Time frame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
Procedural success
Time frame: at discharge
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
1 site 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 1 site 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 1 site 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), and Target Vessel Revascularization (TVR) (time frame: at 12 months after PCI). 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.