Novara Registry of Platinum-Chromium Platform Stents

Study Overview
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Brief Summary
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Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).

Detailed Description
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Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population . Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent. Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.

Official Title
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Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry

Conditions
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Fracture of Stent of Coronary Artery, External Causes of Morbidity and Mortality, Myocardial Infarction, Coronary Vessel Disorders

Intervention / Treatment
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* Device: coronary angioplasty with PtCr stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCI with at least 1 platinum-chromium platform-based stent presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography Exclusion Criteria: age <18 >90

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| PtCr stent PCI treated patients<br>patients treated with PCI in whichat least 1 PtCr stent was used | Device: coronary angioplasty with PtCr stent implantation<br>* PCI with deployment of at least 1 PtCr stent<br>* Other names: Omega platinum Chromium stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA : nominal stent lenght ratio | QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality | death from cardiac or vascular causes | 1 year | 
| myocardial infarction | recurring myocardial infarction (MI), according to the novel 3rd definition of MI | 1 year | 
| target vessel failure | any clinically-driver revascularization of the treated coronary vessel | 1 year | 
| Macroscopical stent deformation | severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platinum-chromium stents, concertina effect, stent deformation, everolimus eluting stents, stent lenght