Novara Registry of Platinum-Chromium Platform Stents

NCT ID: NCT01759719

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Fracture of Stent of Coronary Artery External Causes of Morbidity and Mortality Myocardial Infarction Coronary Vessel Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PtCr stent PCI treated patients

patients treated with PCI in whichat least 1 PtCr stent was used

coronary angioplasty with PtCr stent implantation

Intervention Type DEVICE

PCI with deployment of at least 1 PtCr stent

Interventions

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coronary angioplasty with PtCr stent implantation

PCI with deployment of at least 1 PtCr stent

Intervention Type DEVICE

Other Intervention Names

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Promus Elements platinum Chromium stent Omega platinum Chromium stent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Lupi Alessandro

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Lupi, MD

Role: PRINCIPAL_INVESTIGATOR

AO Maggiore della Carita

Locations

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Ospedale Maggiore della Carità

Novara, Piedmont, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Lupi, M.D.

Role: CONTACT

0039 0321 3733236

Facility Contacts

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Alessandro Lupi, M.D.

Role: primary

0039 0321 3733236

References

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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.

Reference Type DERIVED
PMID: 24993987 (View on PubMed)

Other Identifiers

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0000002

Identifier Type: -

Identifier Source: org_study_id

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