Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)

Study Overview
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Brief Summary
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The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the real world daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

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

Official Title
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Evaluation of Effectiveness and Safety of BIOMATRIX 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 BioMatrix 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 |
| --- | --- |
| Biomatrix stent<br>patients treated with Biomatrix 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 ischemic-driven Target- Vessel Revascularization (TVR) |  | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death |  | one month | 
| All Death |  | 6 months | 
| All Death |  | yearly upto 5 years | 
| Cardiac death |  | one month | 
| Cardiac death |  | 6 months | 
| Cardiac death |  | yearly upto 5 years | 
| MI |  | one month | 
| MI |  | 6 months | 
| MI |  | yearly upto 5 years | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | 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 |  | yearly upto 5 years | 
| TVR |  | one month | 
| TVR |  | 6 months | 
| TVR |  | yearly upto 5 years | 
| Target-lesion revascularization (TLR) |  | one month | 
| Target-lesion revascularization (TLR) |  | 6 months | 
| Target-lesion revascularization (TLR) |  | yearly upto 5 years | 
| Stent thrombosis (ARC criteria) |  | one month | 
| Stent thrombosis (ARC criteria) |  | 6 months | 
| Stent thrombosis (ARC criteria) |  | yearly upto 5 years | 
| 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 | 

 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