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

Jung-min Ahn

Status: Enrolling

Conditions: Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Coronary Disease; Heart Diseases

Treatments: Device: Synergy XD stent or Synergy Megatron™ Stent

Study type: Observational

Funder types: Other

Identifiers

NCT05044273

AMCCV2021-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Coronary Artery Disease

Treatment:

Device: Synergy XD stent or Synergy Megatron™ Stent