NCT05044273

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2022Dec 2031

First Submitted

Initial submission to the registry

September 6, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

September 6, 2021

Last Update Submit

December 21, 2025

Conditions

Coronary Artery DiseaseCardiovascular DiseasesHeart DiseasesMyocardial IschemiaCoronary Disease

Keywords

drug eluting stentpercutaneous coronary interventionreal world

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Coronary Artery Disease

Device: Synergy XD stent or Synergy Megatron™ Stent

Interventions

Synergy XD stent or Synergy Megatron™ StentDEVICE

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

Coronary Artery Disease

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Synergy XD stent or Synergy Megatron™ stent

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Hallym University Medical Center

Anyang, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

TERMINATED

Inje university Pusan Paik hospital

Busan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

TERMINATED

Pusan National University Hospital

Busan, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Samsung Changwon Hospital

Changwon, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Veterans Hospital

Daegu, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, South Korea

RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam, South Korea

TERMINATED

Seoul university Bundang hospital

Seongnam, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

TERMINATED

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

Suwon, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular DiseasesHeart DiseasesMyocardial IschemiaCoronary Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jung-hee Ham, Project Manager

CONTACT

82230104728cvcrc5@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Medicine, Division of Cardiology, Department of Internal Medicine

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 14, 2021

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

KR(23)