Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent
- Conditions
- Cardiovascular DiseasesHeart DiseasesMyocardial IschemiaCoronary Artery DiseaseCoronary Disease
- Interventions
- Device: Synergy XD stent or Synergy Megatron™ Stent
- Registration Number
- NCT05044273
- Lead Sponsor
- Jung-min Ahn
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
- Patients with a mixture of other drug-eluting stents (DESs)
- Terminal illness with life-expectancy ≤1 year.
- Patients with cardiogenic shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Coronary Artery Disease Synergy XD stent or Synergy Megatron™ Stent -
- Primary Outcome Measures
Name Time Method The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization 1 year 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.
- Secondary Outcome Measures
Name Time Method The event rate of all death 5-year The event rate of myocardial infarction 5-year The event rate of target-vessel revascularization 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 cardiac death 5-year The event rate of stent thrombosis 5-year According to Academic Research Consortium(ARC) criteria
The event rate of procedural success 3 days 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.
The event rate of target-lesion revascularization 5-year The event rate of stroke 5-year
Trial Locations
- Locations (21)
Hallym University Medical Center
🇰🇷Anyang, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Samsung Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Veterans Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, ST. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of