PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
NCT ID: NCT01148329
Last Updated: 2017-02-02
Study Results
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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COMPLETED
1010 participants
OBSERVATIONAL
2010-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single arm observational study
To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice
Coronary stenting
The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.
Interventions
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Coronary stenting
The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Pharmaceutical Research Associates
OTHER
Medidata Solutions
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Raul Moreno, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital La Paz, Spain
Peter Maurer, PhD
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Allgemeines Krankenhaus der Stadt Linz
Linz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
Virga Jesse Ziekenhuis
Hasselt, , Belgium
Centre Hôpital Universitaire Sart Tilman
Liège, , Belgium
Odense University Hospital
Odense, , Denmark
Roskilde Sygehus
Roskilde, , Denmark
Centre Hospitalier Privé Saint Martin gds
Caen, , France
Le Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Polyclinique les Fleurs
Ollioules, , France
Clinique St. Martin
Pessac, , France
Clinique Saint-Hilaire Rouen
Rouen, , France
Clinique Pasteur
Toulouse, , France
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Klinikum Leverkusen
Leverkusen, North Rhine-Westphalia, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Klinikum Darmstadt
Darmstadt, , Germany
Med. Hochschule Hannover
Hanover, , Germany
Schwarzwald Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Dept. of Internal Medicine and Cardiological Center
Szeged, , Hungary
Beaumont Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
St. James's Hospital
Dublin, , Ireland
Galway University Hospital
Galway, , Ireland
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Centro Cardiologico Monzino
Milan, , Italy
Clinica Mediterranea
Napoli, , Italy
IRCCS Policlinico S. Matteo
Pavia, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Papworth Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
King's College Hospital London
London, , United Kingdom
Freeman, Newcastle-Upon-Tyne
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07.
Other Identifiers
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S2057
Identifier Type: -
Identifier Source: org_study_id
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