NCT02719106

Brief Summary

The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents.

Trial Health

87
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
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

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

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

March 21, 2016

Last Update Submit

December 22, 2025

Conditions

Keywords

real world datapercutaneous coronary interventiondrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Composite event

    The number of events with the first occurrence of a composite event(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)

Ultimaster stent

Device: Ultimaster stent

Interventions

Ultimaster stent

Eligibility Criteria

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

patients with Ultimaster stent

You may qualify if:

  • Age 19 and more
  • Intervention with Ultimaster stent
  • Agreed with written informed consent form

You may not qualify if:

  • Intervention with Ultimaster 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 (15)

Sejong General hospital

Bucheon-si, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's hospital

Seoul, South Korea

Location

The Catholic University of Korea St. Paul's Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 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
Sponsor-investigator

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

July 20, 2016

Primary Completion

July 24, 2020

Study Completion

August 8, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations