Novara Registry of Platinum-Chromium Platform Stents

• Conditions: Fracture of Stent of Coronary Artery; Coronary Vessel Disorders; Myocardial Infarction; External Causes of Morbidity and Mortality
• Interventions: Device: coronary angioplasty with PtCr stent implantation

• Registration Number: NCT01759719
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-30
• Study First Posted: 2013-01-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PtCr stent PCI treated patients	coronary angioplasty with PtCr stent implantation	patients treated with PCI in whichat least 1 PtCr stent was used

Primary Outcome Measures

Name	Time	Method
QCA : nominal stent lenght ratio	1 day	QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	1 year	death from cardiac or vascular causes
myocardial infarction	1 year	recurring myocardial infarction (MI), according to the novel 3rd definition of MI
target vessel failure	1 year	any clinically-driver revascularization of the treated coronary vessel
Macroscopical stent deformation	1 day	severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)

Trial Locations

Locations (1)

Ospedale Maggiore della Carità; 🇮🇹 Novara, Piedmont, Italy