Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)
|ClinicalTrials.gov Identifier: NCT01759719|
Recruitment Status : Unknown
Verified March 2015 by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was: Recruiting
First Posted : January 3, 2013
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment|
|Fracture of Stent of Coronary Artery External Causes of Morbidity and Mortality Myocardial Infarction Coronary Vessel Disorders||Device: coronary angioplasty with PtCr stent implantation|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2015|
PtCr stent PCI treated patients
patients treated with PCI in whichat least 1 PtCr stent was used
Device: coronary angioplasty with PtCr stent implantation
PCI with deployment of at least 1 PtCr stent
- QCA : nominal stent lenght ratio [ Time Frame: 1 day ]QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation
- cardiovascular mortality [ Time Frame: 1 year ]death from cardiac or vascular causes
- myocardial infarction [ Time Frame: 1 year ]recurring myocardial infarction (MI), according to the novel 3rd definition of MI
- target vessel failure [ Time Frame: 1 year ]any clinically-driver revascularization of the treated coronary vessel
- Macroscopical stent deformation [ Time Frame: 1 day ]severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759719
|Contact: Alessandro Lupi, M.D.||0039 0321 email@example.com|
|Ospedale Maggiore della Carità||Recruiting|
|Novara, Piedmont, Italy, 28100|
|Contact: Alessandro Lupi, M.D. 0039 0321 3733236 firstname.lastname@example.org|
|Principal Investigator: Alessandro Lupi, M.D.|
|Sub-Investigator: Andrea Rognoni, M.D.|
|Principal Investigator:||Alessandro Lupi, MD||AO Maggiore della Carita|