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Clinical Trials/NCT01759719
NCT01759719
Unknown
Not Applicable

Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry

Azienda Ospedaliero Universitaria Maggiore della Carita1 site in 1 country500 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of Stent of Coronary Artery
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Enrollment
500
Locations
1
Primary Endpoint
QCA : nominal stent lenght ratio
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Responsible Party
Principal Investigator
Principal Investigator

Lupi Alessandro

M.D.

Azienda Ospedaliero Universitaria Maggiore della Carita

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • cardiovascular mortality(1 year)
  • myocardial infarction(1 year)
  • target vessel failure(1 year)
  • Macroscopical stent deformation(1 day)

Study Sites (1)

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