Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent (IRIS SynergyXD)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Device: Synergy XD stent or Synergy Megatron™ Stent

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, Project manager; Phone Number: 82230104728; Email: cvcrc5@amc.seoul.kr

Study Locations

• South Korea
  • Anyang, South Korea
    • Recruiting
    • Hallym University Medical Center
    • Principal Investigator: Sang-ho Choi, MD
    • Contact: Sang-ho Choi, MD
  • Busan, South Korea
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jeong-cheon Choi, MD
    • Principal Investigator: Jeong-cheon Choi, MD
  • Busan, South Korea
    • Recruiting
    • Dong-A University Hospital
    • Principal Investigator: Yong-rak Cho, MD
    • Contact: Yong-rak Cho, MD
  • Busan, South Korea
    • Terminated
    • Inje University Busan Paik Hospital
  • Busan, South Korea
    • Recruiting
    • Inje University Pusan Paik Hospital
    • Contact: Tae-hyun Yang, MD
    • Principal Investigator: Tae-hyun Yang, MD
  • Busan, South Korea
    • Terminated
    • Pusan National University Hospital
  • Busan, South Korea
    • Recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Min-gu Cheon, MD
    • Principal Investigator: Min-gu Cheon, MD
  • Changwon, South Korea
    • Recruiting
    • Gyeongsang National University Changwon Hospital
    • Contact: Jae-seok Bae, MD
    • Principal Investigator: Jae-seok Bae, MD
  • Changwon, South Korea
    • Recruiting
    • Samsung Changwon Hospital
    • Contact: Yong-hwan Park, MD
    • Principal Investigator: Yong-hwan Park, MD
  • Daegu, South Korea
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Chul Hyun Lee, MD
    • Principal Investigator: Chul Hyun Lee, MD
  • Daegu, South Korea
    • Recruiting
    • Veterans Hospital
    • Contact: Sang-wook Kang, MD
    • Principal Investigator: Sang-wook Kang, MD
  • Daegu, South Korea
    • Recruiting
    • Yeungnam University Medical Center
    • Principal Investigator: Woong Kim, MD
    • Contact: Woong Kim, MD
  • Gangneung, South Korea
    • Recruiting
    • GangNeung Asan Hospital
    • Contact: Han-bit Park, MD
    • Principal Investigator: Han-bit Park, MD
  • Gwangju, South Korea
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Min-cheol Kim, MD
    • Principal Investigator: Min-cheol Kim, MD
  • Iksan, South Korea
    • Recruiting
    • Wonkwang University Hospital
    • Contact: Kyung Ho Yoon, MD
    • Principal Investigator: Kyung Ho Yoon, MD
  • Seongnam, South Korea
    • Terminated
    • Cha Bundang Medical Center, Cha University
  • Seongnam, South Korea
    • Recruiting
    • Seoul university Bundang hospital
    • Contact: Jung-won Suh, MD; Email: suhjw1@gmail.com
    • Principal Investigator: Jung-won Suh, MD
  • Seoul, South Korea
    • Recruiting
    • Asan Medical Center
    • Contact: Jung-min Ahn, MD
    • Principal Investigator: Jung-min Ahn, MD
  • Seoul, South Korea
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Jae-hyung Park, MD
    • Principal Investigator: Jae-hyung Park, MD
  • Seoul, South Korea
    • Recruiting
    • Hanyang University Seoul Hospital
    • Contact: Young-hyo Lim, MD
    • Principal Investigator: Young-hyo Lim, MD
  • Seoul, South Korea
    • Terminated
    • Korea University Guro Hospital
  • Suwon, South Korea
    • Recruiting
    • The Catholic University of Korea, St. Vincent'S Hospital
    • Contact: Sung-ho Hur, MD
    • Principal Investigator: Sung-ho Hur, MD
  • Ulsan, South Korea
    • Recruiting
    • Ulsan University Hospital
    • Contact: Kyung-min Park, MD
    • Principal Investigator: Kyung-min Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Synergy XD stent or Synergy Megatron™ stent

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with a mixture of other drug-eluting stents (DESs)
• Terminal illness with life-expectancy ≤1 year.
• Patients with cardiogenic shock

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease	Device: Synergy XD stent or Synergy Megatron™ Stent; Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of all death		5-year
The event rate of cardiac death		5-year
The event rate of myocardial infarction		5-year
The composite event rate of death or myocardial infarction		5-year
The composite event rate of cardiac death or myocardial infarction		5-year
The event rate of target-vessel revascularization		5-year
The event rate of target-lesion revascularization		5-year
The event rate of stent thrombosis	According to Academic Research Consortium(ARC) criteria	5-year
The event rate of stroke		5-year
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.	3 days

Collaborators and Investigators

• Sponsor: Jung-min Ahn
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; drug eluting stent; real world
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AMCCV2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No