Clinical trial NCT01392846: The IRIS-Resolute Integrity (IRIS-Integrity)
Official title: Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease requiring drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Medtronic
First posted: 2011-07-13
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery disease requiring drug eluting stents

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.

Detailed description: Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Eligibility criteria: 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

Primary outcomes:
measure: composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Death (all cause and cardiac)
timeFrame: one month
measure: Death (all cause and cardiac)
timeFrame: 6 months
measure: Death (all cause and cardiac)
timeFrame: 12 months and yearly up to 5 years
measure: Myocardial Infarction
timeFrame: one month
measure: Myocardial Infarction
timeFrame: 6 months
measure: Myocardial Infarction
timeFrame: 12 months and yearly upto 5 years
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: 12 months and yearly upto 5 years
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: 12 months and yearly up to 5 years
measure: Target Vessel Revascularization
timeFrame: one month
measure: Target Vessel Revascularization
timeFrame: 6 months
measure: Target Vessel Revascularization
timeFrame: 12 months and yearly up to 5 years
measure: Target-lesion revascularization
timeFrame: one month
measure: Target-lesion revascularization
timeFrame: 6 months
measure: Target-lesion revascularization
timeFrame: 12 months and yearly up to 5 years
measure: Stent thrombosis
timeFrame: one month
measure: Stent thrombosis
timeFrame: 6 months
measure: Stent thrombosis
timeFrame: 12 months and yearly up to 5 years
measure: Stroke
timeFrame: 12 months and yearly up to 5 years
measure: Procedural success
timeFrame: at day 1
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeong-gi
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST.Mary's Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST.Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gang Neung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: