IRIS SynergyXD: Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

Sponsor

Jung-min Ahn (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05044273

Collaborator

CardioVascular Research Foundation, Korea (Other)

1,000

Enrollment

Location

76.6

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Coronary Disease	Device: Synergy XD stent or Synergy Megatron™ Stent

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Coronary Artery Disease	Device: Synergy XD stent or Synergy Megatron™ Stent Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Arm

Intervention/Treatment

Coronary Artery Disease

Device: Synergy XD stent or Synergy Megatron™ Stent

Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Outcome Measures

Primary Outcome Measures

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

The event rate of all death [5-year]
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 target-vessel revascularization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

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.