Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )

Study Overview
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Brief Summary
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This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Detailed Description
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The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions. Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.

Official Title
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Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving Promus Element stents 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 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 |
| --- | --- |
| Promus Element stent<br>Patients receiving Promus Element stents | |

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 ischemic-driven Target- Vessel Revascularization (TVR) |  | 12 months post stenting procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all-cause and cardiac) |  | 30 days | 
| Myocardial infarction |  | 30 days | 
| Composite of death or MI |  | 30 days | 
| Composite of cardiac death or MI |  | 30 days | 
| Target Vessel Revascularization |  | 30 days | 
| Target lesion revascularization |  | 30 days | 
| Stent thrombosis |  | 30 days | 
| Procedural success(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 discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days. | 3 days in average | 
| Death (all cause and cardiac) |  | 6 months | 
| Death (all cause and cardiac) |  | yearly up to 5 years | 
| Myocardial infarction |  | 6 months | 
| Myocardial infarction |  | yearly up to 5 years | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | yearly up to 5 years | 
| Composite of cardiac death or MI |  | 6 months | 
| Composite of cardiac death or MI |  | yearly up to 5 years | 
| Target Vessel Revascularization |  | 6 months | 
| Target Vessel Revascularization |  | yearly up to 5 years | 
| Target lesion revascularization |  | 6 months | 
| Target lesion revascularization |  | yearly up to 5 years | 
| Stent thrombosis |  | 6 months | 
| Stent thrombosis |  | yearly up to 5 years |