NCT03588481

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

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

Study Progress62%
Nov 2018Dec 2030

First Submitted

Initial submission to the registry

July 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

8.1 years

First QC Date

July 5, 2018

Last Update Submit

December 28, 2025

Conditions

Coronary StenosisCoronary OcclusionCoronary Disease

Keywords

PCIDESreal world

Outcome Measures

Primary Outcomes (1)

  • Composite event rate

    Death, non-fatal myocardial infarction, Target Vessel Revascularization

    1year

Secondary Outcomes (10)

  • All death

    5years

  • Cardiac death

    5years

  • Myocardial infarction

    5years

  • Composite event of death or myocardial infarction

    5years

  • Composite event of cardiac death or myocardial infarction

    5years

  • +5 more secondary outcomes

Study Arms (1)

Coronary stenosis

Device: DESyne X2

Interventions

DESyne X2DEVICE

Novolimus-eluting stent

Coronary stenosis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with DeSyne X2 stent

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hallym Hospital

Incheon, South Korea

RECRUITING

Asan Medical Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

WITHDRAWN

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, South Korea

TERMINATED

St.carollo Hospital

Suncheon, South Korea

TERMINATED

MeSH Terms

Conditions

Coronary StenosisCoronary OcclusionCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Jung-hee Ham, RN

CONTACT

82230104728cvcrc5@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 17, 2018

Study Start

November 28, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(6)