Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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