Coronary Artery DiseaseIRIS SynergyNCT02720419
IRIS-Synergy Cohort in the IRIS-DES Registry
An observational study of Coronary Artery Disease, run by Jung-min Ahn at 28 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 28 sitesSouth Korea
- Study dates
- Aug 2016to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Synergy stent
Who may be able to join
- Age 19 and more
- Intervention with Synergy stent
- Agreed with written informed consent form
Who cannot join
- Intervention with Synergy stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
South Korea28 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Haeundae paik hospital, inje university
Busan
Inje university Pusan Paik hospital
Busan
Kosin University Gospel Hospital
Busan
Pusan National University Hospital
Busan
Pusan National University Yangsan Hospital
Busan
Soon Chun Hyang University Hospital
Cheonan
Gangwon National Univ. Hospital
Chuncheon
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Incheon St. Mary's Hospital, The Catholic University of Korea
Incheon
Cheju Halla General Hopsital
Jeju City
Kwangju Christian Hospital
Kwangju
CHA Bundang Medical Center, CHA University
Seongnam
Seoul university Bundang hospital
Seongnam
Asan Medical Center
Seoul
Eulji general hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung-Hee University Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, St. Paul's hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: Evaluation of Effectiveness and Safety of Synergy™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent, percutaneous coronary intervention, real world
- 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 |
|---|---|---|
| Synergy stent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
Measured: 1 year
Secondary outcomes (10)
All death
Measured: 5 years
Cardiac death
Measured: 5 years
Myocardial infarction
Measured: 5 years
Composite event of death or myocardial infarction
Measured: 5 years
Composite event of cardiac death or myocardial infarction
Measured: 5 years
Target vessel revascularization
Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %
Measured: 5 years
Target lesion revascularization
Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: 5 years
Stent thrombosis
DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;
Measured: 5 years
Stroke
Measured: 5 years
Procedural success
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion24 Feb 2023
- Study completionFeb 2027 (estimated)
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 (actual)
Sponsor and investigators
- Lead sponsor
- Jung-min Ahn
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Jung-min Ahn, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720419
- Sponsor's protocol ID
- AMCCV2016-03
- Acronym
- IRIS Synergy
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2016
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Synergy™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02720419
- Acronym / sponsor ID
- IRIS Synergy / AMCCV2016-03
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent, percutaneous coronary intervention, real world
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Jung-min AhnUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Aug 2016 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Mar 2016 (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 purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synergy stent | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Synergy stent
Key inclusion criteria (3 listed)
- Age 19 and more
- Intervention with Synergy stent
- Agreed with written informed consent form
Key exclusion criteria (3 listed)
- Intervention with Synergy stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac 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 event
Time frame: 1 year
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
10 secondary outcomes
All death
Time frame: 5 years
Cardiac death
Time frame: 5 years
Myocardial infarction
Time frame: 5 years
Composite event of death or myocardial infarction
Time frame: 5 years
Composite event of cardiac death or myocardial infarction
Time frame: 5 years
Target vessel revascularization
Time frame: 5 years
Target lesion revascularization
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
Stroke
Time frame: 5 years
Procedural success
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
28 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 Jung-min Ahn at 28 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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
This study is still under way. Results are not available in the source record yet.
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 event (time frame: 1 year). 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 18 Dec 2023.