Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date July 2011
End date July 2016
Trial size 3000 participants
Trial identifier NCT01392846, CVRF2011-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients receiving Resolute-Integrity stent

Primary Outcomes

Measure
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
time frame: 12 months post procedure

Secondary Outcomes

Measure
Death (all cause and cardiac)
time frame: one month
Death (all cause and cardiac)
time frame: 6 months
Death (all cause and cardiac)
time frame: 12 months and yearly up to 5 years
Myocardial Infarction
time frame: one month
Myocardial Infarction
time frame: 6 months
Myocardial Infarction
time frame: 12 months and yearly upto 5 years
Composite of death or MI
time frame: one month
Composite of death or MI
time frame: 6 months
Composite of death or MI
time frame: 12 months and yearly upto 5 years
Composite of cardiac death or MI
time frame: one month
Composite of cardiac death or MI
time frame: 6 months
Composite of cardiac death or MI
time frame: 12 months and yearly up to 5 years
Target Vessel Revascularization
time frame: one month
Target Vessel Revascularization
time frame: 6 months
Target Vessel Revascularization
time frame: 12 months and yearly up to 5 years
Target-lesion revascularization
time frame: one month
Target-lesion revascularization
time frame: 6 months
Target-lesion revascularization
time frame: 12 months and yearly up to 5 years
Stent thrombosis
time frame: one month
Stent thrombosis
time frame: 6 months
Stent thrombosis
time frame: 12 months and yearly up to 5 years
Procedural success
time frame: at day 1

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - 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. Exclusion Criteria: - Patients with a mixture of other DESs - Terminal illness with life expectancy <1 year - Patients presented with cardiogenic shock

Additional Information

Official title Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
Principal investigator Seung-Jung Park, MD, PhD
Description Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.