Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)

University Hospital Maggiore della Carità of Novara

Status: Unknown

Conditions: Fracture of Stent of Coronary Artery; External Causes of Morbidity and Mortality; Coronary Vessel Disorders; Myocardial Infarction

Treatments: Device: coronary angioplasty with PtCr stent implantation

Study type: Observational

Funder types: Other

Identifiers

NCT01759719

0000002

Details and patient eligibility

About

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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

PtCr stent PCI treated patients

Description:

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

Treatment:

Device: coronary angioplasty with PtCr stent implantation