The IRIS-Resolute Integrity (IRIS-Integrity)

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01392846
• Lead Sponsor: Seung-Jung Park

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Primary Completion: 2016-01-20
• Study Completion: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)	12 months post procedure

Secondary Outcome Measures

Name	Time	Method
Target-lesion revascularization	12 months and yearly up to 5 years
Stent thrombosis	12 months and yearly up to 5 years
Stroke	12 months and yearly up to 5 years
Procedural success	at day 1	It is defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
Death (all cause and cardiac)	12 months and yearly up to 5 years
Myocardial Infarction	12 months and yearly upto 5 years
Composite of death or MI	12 months and yearly upto 5 years
Composite of cardiac death or MI	12 months and yearly up to 5 years
Target Vessel Revascularization	12 months and yearly up to 5 years

Trial Locations

Locations (23)

Inje University Ilsan Paik Hospital; 🇰🇷 Ilsan, Gyeong-gi, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

The Catholic University of Korea, Bucheon ST.Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

The Catholic University of Korea, Daejeon ST.Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gang Neung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

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