Evaluation of Effectiveness and Safety of Synergy XD Stent

Overview

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent in the "real world" daily practice as compared with the other drug-eluting stents.

Full Title of Study: “Evaluation of Effectiveness and Safety of Synergy™ XD Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2024

Detailed Description

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stents versus other drug-eluting stents (DES) in patients with coronary artery disease.

Interventions

  • Device: Synergy XD stent
    • Percutaneous coronary intervention with Synergy XD stent

Arms, Groups and Cohorts

  • Coronary Artery Disease

Clinical Trial Outcome Measures

Primary Measures

  • The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization
    • Time Frame: 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 Measures

  • 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
    • According to Academic Research Consortium(ARC) criteria
  • The event rate of stroke
    • Time Frame: 5-year
  • The event rate of procedural success
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ≥ 19 years old – Patients receiving Synergy XD 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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Jung-min Ahn
  • Collaborator
    • CardioVascular Research Foundation, Korea
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jung-min Ahn, MD,PhD, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea – Asan Medical Center
  • Overall Contact(s)
    • Jung-hee Ham, Project Manager, 82230104728, cvcrc5@amc.seoul.kr

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