Clincosm LogoSign in Get a demo

IRIS DESyne X2: IRIS- DESyne X2 in the IRIS-DES Registry

Sponsor
Seung-Jung Park (Other)
Overall Status
Recruiting
CT.gov ID
NCT03588481
Collaborator
CardioVascular Research Foundation, Korea (Other)
1,000
Enrollment
6
Locations
97.1
Anticipated Duration (Months)
166.7
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: DESyne X2

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Actual Study Start Date :
Nov 28, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Coronary stenosis

Device: DESyne X2
Novolimus-eluting stent

Outcome Measures

Primary Outcome Measures

  1. Composite event rate [1year]

    Death, non-fatal myocardial infarction, Target Vessel Revascularization

Secondary Outcome Measures

  1. All death [5years]

  2. Cardiac death [5years]

  3. Myocardial infarction [5years]

  4. Composite event of death or myocardial infarction [5years]

  5. Composite event of cardiac death or myocardial infarction [5years]

  6. Target Vessel revascularization [5years]

  7. Target Lesion revascularization [5years]

  8. Stent thrombosis [5years]

    stent thrombosis as classified by an Academic Research Consortium

  9. Stroke [5years]

  10. Procedural success [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hallym Hospital Incheon Korea, Republic of
2 Asan Medical Hospital Seoul Korea, Republic of
3 Korea University Guro Hospital Seoul Korea, Republic of
4 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of
5 The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Korea, Republic of
6 St.carollo Hospital Suncheon Korea, Republic of

Sponsors and Collaborators

  • Seung-Jung Park
  • CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seung-Jung Park, Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT03588481
Other Study ID Numbers:
  • AMCCV2018-09
First Posted:
Jul 17, 2018
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seung-Jung Park, Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center
PCI
DES
real world
Additional relevant MeSH terms:
Coronary Disease
Coronary Stenosis
Coronary Occlusion

Study Results

No Results Posted as of Sep 13, 2021