NCT02039713

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

January 16, 2014

Last Update Submit

September 6, 2021

Conditions

Keywords

DeSyneAngioplasty, Transluminal, Percutaneous CoronaryCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite event rate

    Death, non fatal myocardial infarction, Target Vessel Revascularization

    1year

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

IRIS DeSyne

DeSyne drug eluting stent group

Device: DeSyne drug eluting stent group

Interventions

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with DeSyne stent

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Sam Anyang Hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Konkuk University Chungju hospital

Chungju, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul Veterans Hospital

Seoul, South Korea

Location

St.carollo Hospital

Suncheon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations