Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)

March 25, 2015 updated by: Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Piedmont
      • Novara, Piedmont, Italy, 28100
        • Recruiting
        • Ospedale Maggiore della Carità
        • Principal Investigator:
          • Alessandro Lupi, M.D.
        • Contact:
        • Sub-Investigator:
          • Andrea Rognoni, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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