Coronary Vessel Disorders, External Causes of Morbidity and Mortality, Fracture of Stent of Coronary Artery, Myocardial Infarction
Conditions
Keywords
platinum-chromium stents, concertina effect, stent deformation, everolimus eluting stents, stent lenght
Brief summary
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
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.
Interventions
DEVICEcoronary angioplasty with PtCr stent implantation
PCI with deployment of at least 1 PtCr stent
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QCA : nominal stent lenght ratio | 1 day | QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular mortality | 1 year | death from cardiac or vascular causes |
| myocardial infarction | 1 year | recurring myocardial infarction (MI), according to the novel 3rd definition of MI |
| target vessel failure | 1 year | any clinically-driver revascularization of the treated coronary vessel |
| Macroscopical stent deformation | 1 day | severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.) |
Countries
Italy
Contacts
Primary ContactAlessandro Lupi, M.D.
Outcome results
None listed