The IRIS-Resolute Integrity (IRIS-Integrity)

Study Overview
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Brief Summary
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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
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Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Official Title
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Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resolute Integrity<br>Patients receiving Resolute-Integrity stent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) |  | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Myocardial Infarction |  | 12 months and yearly upto 5 years | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | 12 months and yearly upto 5 years | 
| Composite of cardiac death or MI |  | one month | 
| Composite of cardiac death or MI |  | 6 months | 
| Composite of cardiac death or MI |  | 12 months and yearly up to 5 years | 
| Target Vessel Revascularization |  | one month | 
| Target Vessel Revascularization |  | 6 months | 
| Target Vessel Revascularization |  | 12 months and yearly up to 5 years | 
| Target-lesion revascularization |  | one month | 
| Target-lesion revascularization |  | 6 months | 
| Target-lesion revascularization |  | 12 months and yearly up to 5 years | 
| Stent thrombosis |  | one month | 
| Stent thrombosis |  | 6 months | 
| Stent thrombosis |  | 12 months and yearly up to 5 years | 
| Stroke |  | 12 months and yearly up to 5 years | 
| Procedural success | 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. | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease requiring drug eluting stents