Novara Registry of Platinum-Chromium Platform Stents

Overview

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).

Full Title of Study: “Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2015

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

  • Device: coronary angioplasty with PtCr stent implantation
    • PCI with deployment of at least 1 PtCr stent

Arms, Groups and Cohorts

  • PtCr stent PCI treated patients
    • patients treated with PCI in whichat least 1 PtCr stent was used

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lupi Alessandro, M.D. – Azienda Ospedaliero Universitaria Maggiore della Carita
  • Overall Official(s)
    • Alessandro Lupi, MD, Principal Investigator, AO Maggiore della Carita
  • Overall Contact(s)
    • Alessandro Lupi, M.D., 0039 0321 3733236, lupialessandro1@tin.it

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