Novara Registry of Platinum-Chromium Platform Stents
PROMETEUS
Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
1 other identifier
observational
500
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 26, 2015
March 1, 2015
3.8 years
December 16, 2012
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
cardiovascular mortality
1 year
myocardial infarction
1 year
target vessel failure
1 year
Macroscopical stent deformation
1 day
Study Arms (1)
PtCr stent PCI treated patients
patients treated with PCI in whichat least 1 PtCr stent was used
Interventions
PCI with deployment of at least 1 PtCr stent
Eligibility Criteria
253 consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 with PCI using a platinum-chromium platform based DES
You may qualify if:
- 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
You may not qualify if:
- age \<18 \>90
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Maggiore della Carità
Novara, Piedmont, 28100, Italy
Related Publications (1)
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.
PMID: 24993987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Lupi, MD
AO Maggiore della Carita
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
December 16, 2012
First Posted
January 3, 2013
Study Start
January 1, 2012
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
March 26, 2015
Record last verified: 2015-03