NCT02720419

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

28 active sites

Status
active not 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 Progress93%
Aug 2016Feb 2027

First Submitted

Initial submission to the registry

March 22, 2016

Completed
3 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

August 1, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

6.6 years

First QC Date

March 22, 2016

Last Update Submit

December 15, 2023

Conditions

Keywords

drug eluting stentpercutaneous coronary interventionreal world

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)

    1 year

Secondary Outcomes (10)

  • All death

    5 years

  • Cardiac death

    5 years

  • Myocardial infarction

    5 years

  • Composite event of death or myocardial infarction

    5 years

  • Composite event of cardiac death or myocardial infarction

    5 years

  • +5 more secondary outcomes

Study Arms (1)

Synergy stent

Eligibility Criteria

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

Patients with Synergy stent

You may qualify if:

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

You may not qualify if:

  • Intervention with Synergy 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 (28)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Haeundae paik hospital, inje university

Busan, South Korea

Location

Inje university Pusan Paik hospital

Busan, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Pusan National University Yangsan Hospital

Busan, South Korea

Location

Soon Chun Hyang University Hospital

Cheonan, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, 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

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

Incheon, South Korea

Location

Cheju Halla General Hopsital

Jeju City, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam, South Korea

Location

Seoul university Bundang hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Eulji general hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung-Hee University Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

The Catholic University of Korea, St. Paul's hospital

Seoul, 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
assistant professor

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 25, 2016

Study Start

August 1, 2016

Primary Completion

February 24, 2023

Study Completion (Estimated)

February 1, 2027

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations