IRIS- DESyne X2 in the IRIS-DES Registry (IRIS DESyne X2)

December 17, 2023 updated by: Seung-Jung Park

Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Recruiting
        • Hallym Hospital
        • Contact:
          • Soo-han Kim, MD
        • Principal Investigator:
          • Soo-han Kim, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • SEUNG-UN NA, MD
        • Principal Investigator:
          • SEUNG-UN NA, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Hospital
        • Contact:
          • Seung-jung Park, MD
        • Principal Investigator:
          • Seung-jung Park, MD
      • Seoul, Korea, Republic of
        • Withdrawn
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of
        • Terminated
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Suncheon, Korea, Republic of
        • Terminated
        • St.Carollo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with DeSyne X2 stent

Description

Inclusion Criteria:

  • Age 19 and more
  • Intervention with DeSyne X2 drug-eluting coronary stent
  • Agreed with written informed consent form

Exclusion Criteria:

  • Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
  • Life expectancy of 1year and under
  • Cardiac shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary stenosis
Device: DESyne X2
Novolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All death
Time Frame: 5years
5years
Cardiac death
Time Frame: 5years
5years
Myocardial infarction
Time Frame: 5years
5years
Composite event of death or myocardial infarction
Time Frame: 5years
5years
Composite event of cardiac death or myocardial infarction
Time Frame: 5years
5years
Stroke
Time Frame: 5years
5years
Target Vessel revascularization
Time Frame: 5years
5years
Target Lesion revascularization
Time Frame: 5years
5years
Stent thrombosis
Time Frame: 5years
stent thrombosis as classified by an Academic Research Consortium
5years
Procedural success
Time Frame: 3days

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.
3days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2018-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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