NCT01392846

Brief Summary

This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.

Trial Health

87
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
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

23 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

July 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2016

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

4.6 years

First QC Date

July 11, 2011

Last Update Submit

September 6, 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 target- Vessel Revascularization (TVR)

    12 months post procedure

Secondary Outcomes (23)

  • Death (all cause and cardiac)

    one month

  • Death (all cause and cardiac)

    6 months

  • Death (all cause and cardiac)

    12 months and yearly up to 5 years

  • Myocardial Infarction

    one month

  • Myocardial Infarction

    6 months

  • +18 more secondary outcomes

Study Arms (1)

Resolute Integrity

Patients receiving Resolute-Integrity stent

Eligibility Criteria

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

patients with coronary artery disease requiring drug eluting stents

You may qualify if:

  • Patients with significant coronary artery disease and receiving Resolute Integrity stent.
  • 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 presented with cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

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

Bucheon-si, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

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

Daejeon, South Korea

Location

Gang Neung Asan Hospital

Gangneung, 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

Presbyterian Medical Center

Jeonju, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

St.carollo Hospital

Suncheon, South Korea

Location

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

Uijeongbu-si, South Korea

Location

Ulsan University Hospital

Ulsan, 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

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

July 11, 2011

First Posted

July 13, 2011

Study Start

July 1, 2011

Primary Completion

January 20, 2016

Study Completion

March 2, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

KR(23)