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Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)

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ClinicalTrials.gov Identifier: NCT01759719
Recruitment Status : Unknown
Verified March 2015 by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was:  Recruiting
First Posted : January 3, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, 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).

Condition or disease Intervention/treatment
Fracture of Stent of Coronary Artery External Causes of Morbidity and Mortality Myocardial Infarction Coronary Vessel Disorders 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 [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
Study Start Date : January 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Chromium
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. cardiovascular mortality [ Time Frame: 1 year ]
    death from cardiac or vascular causes

  2. myocardial infarction [ Time Frame: 1 year ]
    recurring myocardial infarction (MI), according to the novel 3rd definition of MI

  3. target vessel failure [ Time Frame: 1 year ]
    any clinically-driver revascularization of the treated coronary vessel

  4. Macroscopical stent deformation [ Time Frame: 1 day ]
    severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759719


Contacts
Contact: Alessandro Lupi, M.D. 0039 0321 3733236 lupialessandro1@tin.it

Locations
Italy
Ospedale Maggiore della Carità Recruiting
Novara, Piedmont, Italy, 28100
Contact: Alessandro Lupi, M.D.    0039 0321 3733236    lupialessandro1@tin.it   
Principal Investigator: Alessandro Lupi, M.D.         
Sub-Investigator: Andrea Rognoni, M.D.         
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AO Maggiore della Carita

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lupi Alessandro, M.D., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01759719     History of Changes
Other Study ID Numbers: 0000002
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:
platinum-chromium stents
concertina effect
stent deformation
everolimus eluting stents
stent lenght

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Chromium
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances