Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorJung-min Ahn

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a mixture of other drug-eluting stents (DESs)

Terminal illness with life-expectancy ≤1 year.

Patients with cardiogenic shock

Trial population

Patients with Synergy XD stent or Synergy Megatron™ stent

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Synergy XD stent or Synergy Megatron™ Stent

    Device

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

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease1 intervention

Trial outcomes

Primary outcomes

1

The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization

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.

Time frame
1 year

Secondary outcomes

1

The event rate of all death

Time frame
5-year
2

The event rate of cardiac death

Time frame
5-year
3

The event rate of myocardial infarction

Time frame
5-year
4

The composite event rate of death or myocardial infarction

Time frame
5-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jung-min Ahn

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator