Novara Registry of Platinum-Chromium Platform Stents

Myocardial Infarction Clinical Trial

— PROMETEUS  

Official title:

Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01759719
• Other study ID #: 0000002
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2012
• Last updated: March 25, 2015
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Alessandro Lupi, M.D.
• Phone: 0039 0321 3733236
• Email: lupialessandro1[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Vessel Disorders
• External Causes of Morbidity and Mortality
• Fracture of Stent of Coronary Artery
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Maggiore della Carità	Novara	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QCA : nominal stent lenght ratio	QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation	1 day	Yes
Secondary	cardiovascular mortality	death from cardiac or vascular causes	1 year	Yes
Secondary	myocardial infarction	recurring myocardial infarction (MI), according to the novel 3rd definition of MI	1 year	Yes
Secondary	target vessel failure	any clinically-driver revascularization of the treated coronary vessel	1 year	Yes
Secondary	Macroscopical stent deformation	severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)	1 day	Yes