Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia
Conditions
Keywords
drug eluting stent, percutaneous coronary intervention, real world
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.
Interventions
DEVICESynergy XD stent or Synergy Megatron™ Stent
Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent
Sponsors
CardioVascular Research Foundation, Korea
Jung-min Ahn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 all death | 5-year | — |
| The event rate of target-lesion revascularization | 5-year | — |
| The event rate of stent thrombosis | 5-year | According to Academic Research Consortium(ARC) criteria |
| The event rate of stroke | 5-year | — |
| 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-vessel revascularization | 5-year | — |
Countries
South Korea
Contacts
Primary ContactJung-hee Ham, Project Manager
Outcome results
None listed