Clinical trial NCT01242696: TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)
Official title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Drug Eluting Stents
Observational
All-Comers
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2010-11-17
Enrollment: 1014
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who are candidates for coronary artery stenting, signed the Informed Consent Form and are eligible to receive a TAXUS Element stent will be evaluated for enrollment in this study.

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

Detailed description: A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.

Eligibility criteria: Inclusion Criteria:

* According to Instructions For Use

Exclusion Criteria:

* Contraindications according to Instructions for Use

Primary outcomes:
measure: Target Vessel failure
timeFrame: 1 year
Secondary outcomes:
measure: Stent Thrombosis
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: MACE
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: Cardiac Death or MI
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: TVR
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: Cardiac Death
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: MI
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: All Death
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: Non-Cardiac Death
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
measure: All Death or MI
timeFrame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan
city: Charleroi
country: Belgium
facility: CHU de Charleroi - ISPPC
city: Roeselare
country: Belgium
facility: H-Hartziekenhuis Roeselare-Menen vzw
city: Avignon
country: France
facility: CH Avignon
city: Besancon
country: France
facility: CHU Besancon
city: Caen
country: France
facility: Centre Hospitalier Privé Saint Martin gds
city: Grenoble
country: France
facility: CHU Grenoble
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Pau
country: France
facility: CHG de Pau
city: Rouen
country: France
facility: Clinique Saint-Hilaire Rouen
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueuil
city: Frankfurt
country: Germany
facility: Kardiocentrum Frankfurt
state: Hessen
city: Trier
country: Germany
facility: Krankenhaus d. Barmherzigen Brüder
state: Rheinland Pfalz
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
city: Dresden
country: Germany
facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
city: Dusseldorf
country: Germany
facility: Augusta Krankenhaus
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Pecs
country: Hungary
facility: Medical School of University PECS
city: Galway
country: Ireland
facility: Galway University Hospital
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Catania
country: Italy
facility: Ospedale Cannizzaro
city: Grosseto
country: Italy
facility: Ospedale Misericordia ASL 9
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Grodzisk Mazowiecki
country: Poland
facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: León
country: Spain
facility: Hospital General De Leon
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santander
country: Spain
facility: H. Marques De Valdecilla
city: Craigavon
country: United Kingdom
facility: Craigavon Hospital, Southern Trust
state: Northern Ireland
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
city: Hertfordshire
country: United Kingdom
facility: Lister
city: London
country: United Kingdom
facility: London Chest Hospital
city: Newcastle upon -Tyne
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Trust
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
name: Corrado Tamburino, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Peter Maurer, PhD
role: STUDY_DIRECTOR
References:
citation: Tamburino C, Capodanno D, Erglis A, Menown IB, Horvath IG, Moreno R, Gilbert TJ, Crowley JJ, Calabria P, Allocco DJ, Dawkins KD. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015 Mar;10(11):1261-6. doi: 10.4244/EIJY15M01_01.