NCT01350778

Brief Summary

The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
837

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

20 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

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

6.2 years

First QC Date

May 4, 2011

Last Update Submit

January 26, 2021

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease requiring drug eluting stents

Outcome Measures

Primary Outcomes (1)

  • composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    12 months post procedure

Secondary Outcomes (25)

  • All Death

    one month

  • All Death

    6 months

  • All Death

    yearly upto 5 years

  • Cardiac death

    one month

  • Cardiac death

    6 months

  • +20 more secondary outcomes

Study Arms (1)

Biomatrix stent

patients treated with Biomatrix stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving BioMatrix stents

You may qualify if:

  • Patients receiving BioMatrix stents
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

You may not qualify if:

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy \<1 year
  • Patients with cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Ilsan, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Eulji general hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

The Catholic University of Korea St. Paul's Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

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

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Seung-Jung Park, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Ki Bae Seung, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 10, 2011

Study Start

May 1, 2010

Primary Completion

July 1, 2016

Study Completion

August 14, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

KR(20)