Clinical trial NCT05044273: Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent
Official title: Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Disease
Keywords: drug eluting stent
percutaneous coronary intervention
real world
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2021-09-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Synergy XD stent or Synergy Megatron™ stent

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.

Eligibility criteria: 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

Primary outcomes:
measure: The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization
timeFrame: 1 year
Secondary outcomes:
measure: The event rate of all death
timeFrame: 5-year
measure: The event rate of cardiac death
timeFrame: 5-year
measure: The event rate of myocardial infarction
timeFrame: 5-year
measure: The composite event rate of death or myocardial infarction
timeFrame: 5-year
measure: The composite event rate of cardiac death or myocardial infarction
timeFrame: 5-year
measure: The event rate of target-vessel revascularization
timeFrame: 5-year
measure: The event rate of target-lesion revascularization
timeFrame: 5-year
measure: The event rate of stent thrombosis
timeFrame: 5-year
measure: The event rate of stroke
timeFrame: 5-year
measure: The event rate of procedural success
timeFrame: 3 days
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje university Pusan Paik hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Veterans Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seongnam
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: