DESyne in Routine Clinical Practice (IRIS DESYNE)

Evaluation of Effectiveness and Safety of DESyne in Routine Clinical Practice; A Multicenter, Prospective Observational Study

The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine Clinical Practice

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Device: DeSyne drug eluting stent group

• Study Type: Observational
• Enrollment (Actual): 342

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Sam Anyang Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Chuncheon, Korea, Republic of
    • Hallym University Chuncheon Sacred Heart Hospital
  • Chungju, Korea, Republic of
    • Konkuk University Chungju hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Christian hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Seoul Veterans Hospital
  • Suncheon, Korea, Republic of
    • St.carollo Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with DeSyne stent

Description

Inclusion Criteria:

• Age 20 and more
• Intervention with DeSyne drug eluting coronary stent
• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with DeSyne drug eluting coronary stent and other drug eluting stent at the same time
• Life expectancy of 1year and under
• Cardiac shock

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IRIS DeSyne; DeSyne drug eluting stent group	Device: DeSyne drug eluting stent group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event rate	Death, non fatal myocardial infarction, Target Vessel Revascularization	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days.	3day
All death		5year
Cardiac death		5year
Myocardial infarction		5year
Composite event of death or myocardial infarction		5year
Composite event of cardiac death or myocardial infarction		5year
Target Vessel revascularization		5year
Stroke		5year
Target Lesion revascularization		5year
Stent thrombosis	stent thrombosis as classified by an Academic Research Consortium	5year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea; Amg Korea Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary; DeSyne
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AMCCV2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.