Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)

Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry

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).

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Recruiting
      • Ospedale Maggiore della Carità
      • Principal Investigator: Alessandro Lupi, M.D.
      • Contact: Alessandro Lupi, M.D.; Phone Number: 0039 0321 3733236; Email: lupialessandro1@tin.it
      • Sub-Investigator: Andrea Rognoni, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 with PCI using a platinum-chromium platform based DES

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PtCr stent PCI treated patients; patients treated with PCI in whichat least 1 PtCr stent was used	Device: coronary angioplasty with PtCr stent implantation; PCI with deployment of at least 1 PtCr stent; Other Names: Promus Elements platinum Chromium stent; Omega platinum Chromium stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

General Publications

• Lupi A, Porto I, Rognoni A, Lazzero M, Fattori R, Parisi R, De Maria GL, Bongo AS, Sheiban I, Bolognese L, Agostoni P, Secco GG; Novara-PROMETEUS (Platinum ChROMium Everolimus EluTing StEnt SpontaneoUs RegiStry) Investigators. Clinical and biomechanical behavior of a platinum-chromium stent platform in a large all-comer single-center population: insights from the Novara-PROMETEUS registry. J Invasive Cardiol. 2014 Jul;26(7):311-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 16, 2012
• First Submitted That Met QC Criteria: December 30, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: platinum-chromium stents; concertina effect; stent deformation; everolimus eluting stents; stent lenght
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium
• Other Study ID Numbers: 0000002