AzTrials
AzTrials

Coronary Artery DiseaseIRIS SynergyXDNCT05044273

Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Jung-min Ahn at 23 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Synergy XD stent or Synergy Megatron™ Stent
Type of treatment
Medical device
How many people
2,000 participants
Where
23 sitesSouth Korea
Study dates
1 Sep 2022to 31 Dec 2031
How long will I take part?
5 Years
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
  • Adult, Older adult

Study population: Patients with Synergy XD stent or Synergy Megatron™ stent

Who may be able to join

  • Patients ≥ 19 years old
  • Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s).
  • 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 drug-eluting stents (DESs)
  • Terminal illness with life-expectancy ≤1 year.
  • Patients with cardiogenic shock

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jung-hee Ham, Project Manager contact

82230104728

cvcrc5@amc.seoul.kr

23 sites in 1 country

South Korea23 sites, 19 recruiting

  • Hallym University Medical Center

    Anyang

    Sang-ho Choi, MD

    Sang-ho Choi, MD

    Recruiting

  • Dong-A University Hospital

    Busan

    Yong-rak Cho, MD

    Yong-rak Cho, MD

    Recruiting

  • Inje University Busan Paik Hospital

    Busan

    Terminated

  • Inje university Pusan Paik hospital

    Busan

    Tae-hyun Yang, MD

    Tae-hyun Yang, MD

    Recruiting

  • Pusan National University Hospital

    Busan

    Terminated

  • Pusan National University Hospital

    Busan

    Jeong-cheon Choi, MD

    Jeong-cheon Choi, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Busan

    Min-gu Cheon, MD

    Min-gu Cheon, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae-seok Bae, MD

    Jae-seok Bae, MD

    Recruiting

  • Samsung Changwon Hospital

    Changwon

    Yong-hwan Park, MD

    Yong-hwan Park, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chul Hyun Lee, MD

    Chul Hyun Lee, MD

    Recruiting

  • Veterans Hospital

    Daegu

    Sang-wook Kang, MD

    Sang-wook Kang, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Woong Kim, MD

    Woong Kim, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han-bit Park, MD

    Han-bit Park, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Min-cheol Kim, MD

    Min-cheol Kim, MD

    Recruiting

  • Wonkwang University Hospital

    Iksan

    Kyung Ho Yoon, MD

    Kyung Ho Yoon, MD

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam

    Terminated

  • Seoul university Bundang hospital

    Seongnam

    Jung-won Suh, MD, suhjw1@gmail.com

    Jung-won Suh, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Jung-min Ahn, MD

    Jung-min Ahn, MD

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Young-hyo Lim, MD

    Young-hyo Lim, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Jae-hyung Park, MD

    Jae-hyung Park, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Terminated

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon

    Sung-ho Hur, MD

    Sung-ho Hur, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Kyung-min Park, MD

    Kyung-min Park, MD

    Recruiting

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents.

Read the detailed description

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stents versus other drug-eluting stents (DES) in patients with coronary artery disease.

Being tested
Synergy XD stent or Synergy Megatron™ Stent
Keywords
drug eluting stent, percutaneous coronary intervention, real world
Medical subject headings
Coronary Artery Disease, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synergy XD stent or Synergy Megatron™ StentDevice

    Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Study groups in NCT05044273
Study groupRoleWhat they receive
Coronary Artery DiseaseNot described
Receives: Device: Synergy XD stent or Synergy Megatron™ Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.

    Measured: 1 year

Secondary outcomes (10)

  1. The event rate of all death

    Measured: 5-year

  2. The event rate of cardiac death

    Measured: 5-year

  3. The event rate of myocardial infarction

    Measured: 5-year

  4. The composite event rate of death or myocardial infarction

    Measured: 5-year

  5. The composite event rate of cardiac death or myocardial infarction

    Measured: 5-year

  6. The event rate of target-vessel revascularization

    Measured: 5-year

  7. The event rate of target-lesion revascularization

    Measured: 5-year

  8. The event rate of stent thrombosis

    According to Academic Research Consortium(ARC) criteria

    Measured: 5-year

  9. The event rate of stroke

    Measured: 5-year

  10. The event rate of procedural success

    Defined as achievement of final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave myocardial infarction, or urgent revascularization during the index hospitalization.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2021
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

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 (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044273
Sponsor's protocol ID
AMCCV2021-02
Acronym
IRIS SynergyXD
Status last verified
Dec 2025
First submitted
6 Sep 2021
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Jung-min Ahn at 23 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

Contact Jung-hee Ham, Project Manager (82230104728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044273.

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 29 Dec 2025.

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