Coronary Artery DiseaseNCT01350791
Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,001 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Dec 2016
- 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: Coronary artery disease requiring drug eluting stents
Who may be able to join
- Patients receiving Promus Element 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 PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
Read the detailed description
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.
- 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 |
|---|---|---|
| Promus Element stent | Patients receiving Promus Element stents |
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 stenting procedure
Secondary outcomes (22)
Death (all-cause and cardiac)
Measured: 30 days
Myocardial infarction
Measured: 30 days
Composite of death or MI
Measured: 30 days
Composite of cardiac death or MI
Measured: 30 days
Target Vessel Revascularization
Measured: 30 days
Target lesion revascularization
Measured: 30 days
Stent thrombosis
Measured: 30 days
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)
At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
Measured: 3 days in average
Death (all cause and cardiac)
Measured: 6 months
Death (all cause and cardiac)
Measured: yearly up to 5 years
Myocardial infarction
Measured: 6 months
Myocardial infarction
Measured: yearly up to 5 years
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: 6 months
Composite of cardiac death or MI
Measured: yearly up to 5 years
Target Vessel Revascularization
Measured: 6 months
Target Vessel Revascularization
Measured: yearly up to 5 years
Target lesion revascularization
Measured: 6 months
Target lesion revascularization
Measured: yearly up to 5 years
Stent thrombosis
Measured: 6 months
Stent thrombosis
Measured: yearly up to 5 years
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 startMay 2010
- Primary completionOct 2013
- Study completionDec 2016
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
- 3,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Boston Scientific 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
- NCT01350791
- Sponsor's protocol ID
- CVRF2010-04
- Status last verified
- Jul 2017
- First submitted
- 22 Apr 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT01350791
- Acronym / sponsor ID
- CVRF2010-04
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,001 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Boston Scientific Corporation
- Study start
- May 2010 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2016 (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.
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
Detailed description
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Promus Element stent | – | –Patients receiving Promus Element stents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Coronary artery disease requiring drug eluting stents
Key inclusion criteria (2 listed)
- Patients receiving Promus Element 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 stenting procedure
22 secondary outcomes
Death (all-cause and cardiac)
Time frame: 30 days
Myocardial infarction
Time frame: 30 days
Composite of death or MI
Time frame: 30 days
Composite of cardiac death or MI
Time frame: 30 days
Target Vessel Revascularization
Time frame: 30 days
Target lesion revascularization
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
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: 3 days in average
Death (all cause and cardiac)
Time frame: 6 months
Death (all cause and cardiac)
Time frame: yearly up to 5 years
Myocardial infarction
Time frame: 6 months
Myocardial infarction
Time frame: yearly 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
Composite of cardiac death or MI
Time frame: 6 months
Composite of cardiac death or MI
Time frame: yearly up to 5 years
Target Vessel Revascularization
Time frame: 6 months
Target Vessel Revascularization
Time frame: yearly up to 5 years
Target lesion revascularization
Time frame: 6 months
Target lesion revascularization
Time frame: yearly up to 5 years
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: yearly up to 5 years
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 21 Jul 2017.
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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
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 21 Jul 2017. 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), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 12 months post stenting 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 21 Jul 2017.