Clinical trial NCT01759719: Novara Registry of Platinum-Chromium Platform Stents
Official title: Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture of Stent of Coronary Artery
External Causes of Morbidity and Mortality
Myocardial Infarction
Coronary Vessel Disorders
Keywords: platinum-chromium stents
concertina effect
stent deformation
everolimus eluting stents
stent lenght
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 with PCI using a platinum-chromium platform based DES

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.

Eligibility criteria: 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

Primary outcomes:
measure: QCA : nominal stent lenght ratio
timeFrame: 1 day
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: 1 year
measure: myocardial infarction
timeFrame: 1 year
measure: target vessel failure
timeFrame: 1 year
measure: Macroscopical stent deformation
timeFrame: 1 day
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
state: Piedmont
Study officials:
affiliation: AO Maggiore della Carita
name: Alessandro Lupi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lupi A, Porto I, Rognoni A, Lazzero M, Fattori R, Parisi R, De Maria GL, Bongo AS, Sheiban I, Bolognese L, Agostoni P, Secco GG; Novara-PROMETEUS (Platinum ChROMium Everolimus EluTing StEnt SpontaneoUs RegiStry) Investigators. Clinical and biomechanical behavior of a platinum-chromium stent platform in a large all-comer single-center population: insights from the Novara-PROMETEUS registry. J Invasive Cardiol. 2014 Jul;26(7):311-7.