Actively Recruiting

Age: 19Years +
All Genders
ID05044273

Evaluation of Effectiveness and Safety of Synergy122 XD Stent and Synergy Megatron122 Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Led by Jung-min Ahn · Updated on 2025-12-29

2000

Participants Needed

23

Research Sites

260 weeks

Total Duration

On this page

Sponsors

J

Jung-min Ahn

Lead Sponsor

C

CardioVascular Research Foundation, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the Synergy XD stent and Synergy Megatron122 Stent compared to other drug-eluting stents in patients with coronary artery disease. This study is a non-randomized, prospective, open-label registry designed to observe how these stents perform in real-world daily medical practice. The study aims to provide important information about outcomes such as death, heart attack, and the need for further vessel treatment. The study involves patients who receive percutaneous coronary intervention using either the Synergy XD stent or the Synergy Megatron122 stent. These devices are compared against other drug-eluting stents used in similar patients. Participants are followed over time with no random assignment to groups, allowing researchers to assess outcomes based on routine clinical care. Participants will be monitored through scheduled clinical follow-ups, with researchers tracking events including death, non-fatal myocardial infarction, and target vessel revascularization over one year. Additional outcomes such as cardiac death, stroke, stent thrombosis, and procedural success are assessed up to five years after treatment. The study collects data on patient safety and effectiveness of these stents during routine use, providing valuable long-term information on their clinical performance.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 19 years old or older
  • Patients receiving Synergy XD stent(s) or Synergy Megatron122 stent(s)
  • Patient or guardian agrees to the study protocol, follow-up schedule, and provides informed written consent approved by the Institutional Review Board/Ethics Committee
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent as part of their routine clinical care.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for up to 5 years to assess safety and effectiveness outcomes following stent implementation.

Scheduled follow-up visits during the 5-year period

Trial Site Locations

Total: 23 locations

1

Hallym University Medical Center

Anyang, South Korea

Actively Recruiting

2

Dong-A University Hospital

Busan, South Korea

Actively Recruiting

3

Inje University Busan Paik Hospital

Busan, South Korea

Terminated

4

Inje university Pusan Paik hospital

Busan, South Korea

Actively Recruiting

5

Pusan National University Hospital

Busan, South Korea

Terminated

6

Pusan National University Hospital

Busan, South Korea

Actively Recruiting

7

Pusan National University Yangsan Hospital

Busan, South Korea

Actively Recruiting

8

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Actively Recruiting

9

Samsung Changwon Hospital

Changwon, South Korea

Actively Recruiting

10

Keimyung University Dongsan Medical Center

Daegu, South Korea

Actively Recruiting

11

Veterans Hospital

Daegu, South Korea

Actively Recruiting

12

Yeungnam University Medical Center

Daegu, South Korea

Actively Recruiting

13

Gangneung Asan Hospital

Gangneung, South Korea

Actively Recruiting

14

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

15

Wonkwang University Hospital

Iksan, South Korea

Actively Recruiting

16

CHA Bundang Medical Center, CHA University

Seongnam, South Korea

Terminated

17

Seoul university Bundang hospital

Seongnam, South Korea

Actively Recruiting

18

Asan Medical Center

Seoul, South Korea

Actively Recruiting

19

Hanyang University Seoul Hospital

Seoul, South Korea

Actively Recruiting

20

Korea University Anam Hospital

Seoul, South Korea

Actively Recruiting

21

Korea University Guro Hospital

Seoul, South Korea

Terminated

22

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

Suwon, South Korea

Actively Recruiting

23

Ulsan University Hospital

Ulsan, South Korea

Actively Recruiting

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Research Team

J

Jung-hee Ham, Project Manager

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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