Trials / Unknown
UnknownNCT01759719
Novara Registry of Platinum-Chromium Platform Stents
Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Fracture of Stent of Coronary Artery
- External Causes of Morbidity and Mortality
- Myocardial Infarction
- Coronary Vessel Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | coronary angioplasty with PtCr stent implantation | PCI with deployment of at least 1 PtCr stent |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2013-01-03
- Last updated
- 2015-03-26
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01759719. Inclusion in this directory is not an endorsement.