Novara Registry of Platinum-Chromium Platform Stents (PROMETEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01759719
First received: December 16, 2012
Last updated: December 30, 2012
Last verified: December 2012
  Purpose

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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration: 1 Year
Official Title: Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • QCA : nominal stent lenght ratio [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation


Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    death from cardiac or vascular causes

  • myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    recurring myocardial infarction (MI), according to the novel 3rd definition of MI

  • target vessel failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    any clinically-driver revascularization of the treated coronary vessel

  • Macroscopical stent deformation [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)


Enrollment: 253
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759719

Locations
Italy
Ospedale Maggiore della Carità
Novara, Piedmont, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AO Maggiore della Carita
  More Information

No publications provided

Responsible Party: Lupi Alessandro, M.D., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01759719     History of Changes
Other Study ID Numbers: 0000002
Study First Received: December 16, 2012
Last Updated: December 30, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by 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
Chromium
Everolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014