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Recruiting NCT05044273

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

— Observational Coronary Artery Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synergy XD stent or Synergy Megatron™ Stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization [Time frame: 1 year]
Secondary outcome measures (10)
  • The event rate of all death [Time frame: 5-year]
  • The event rate of cardiac death [Time frame: 5-year]
  • The event rate of myocardial infarction [Time frame: 5-year]
  • The composite event rate of death or myocardial infarction [Time frame: 5-year]
  • The composite event rate of cardiac death or myocardial infarction [Time frame: 5-year]
  • The event rate of target-vessel revascularization [Time frame: 5-year]
  • The event rate of target-lesion revascularization [Time frame: 5-year]
  • The event rate of stent thrombosis [Time frame: 5-year]
  • The event rate of stroke [Time frame: 5-year]
  • The event rate of procedural success [Time frame: 3 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

South Korea · 23 centers
  • Hallym University Medical Center — Anyang
  • Dong-A University Hospital — Busan
  • Inje University Busan Paik Hospital — Busan
  • Inje university Pusan Paik hospital — Busan
  • Pusan National University Hospital — Busan
  • Pusan National University Hospital — Busan
  • Pusan National University Yangsan Hospital — Busan
  • Gyeongsang National University Changwon Hospital — Changwon
  • … and 15 more centers

Identifiers

NCT: NCT05044273 · AMCCV2021-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗