Clinical trial NCT01148329: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
Official title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Coronary stenting
Drug-eluting stent
Post-market surveillance study
Promus Element stent
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
name: Medidata Solutions
First posted: 2010-06-22
Enrollment: 1010
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are candidates for Coronary artery stenting, signed the Informed Consent Form and are eligible to receive a PROMUS™ Element™ stent will be evaluated for enrollment in this study.

Brief summary: The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* According to Instructions For Use

Exclusion Criteria:

* Contraindications according to Instructions for Use

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: One year
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: Death or MI rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: TVR rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: Cardiac death rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: MI Rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: All death rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: Non-cardiac death rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
measure: All death or MI rates
timeFrame: 30 days, 6 months, 12 months and then annually through 5 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Liege
country: Belgium
facility: Centre Hôpital Universitaire Sart Tilman
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Caen
country: France
facility: Centre Hospitalier Privé Saint Martin gds
city: Le Plessis Robinson
country: France
facility: Le Centre Chirurgical Marie Lannelongue
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Pessac
country: France
facility: Clinique St. Martin
city: Rouen
country: France
facility: Clinique Saint-Hilaire Rouen
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: NRW
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: NRW
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
state: NRW
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Hannover
country: Germany
facility: Med. Hochschule Hannover
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald Baar Klinikum Villingen-Schwenningen
city: Szeged
country: Hungary
facility: Dept. of Internal Medicine and Cardiological Center
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: London
country: United Kingdom
facility: King's College Hospital London
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Freeman, Newcastle-Upon-Tyne
Study officials:
affiliation: Hospital La Paz, Spain
name: Raul Moreno, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Peter Maurer, PhD
role: STUDY_DIRECTOR
References:
citation: 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.