TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)
TE-Prove
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
1 other identifier
observational
1,014
10 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 3, 2017
February 1, 2017
2.3 years
November 16, 2010
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Vessel failure
Overall and TAXUS Element stent related Target Vessel Failure (TVF) rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation
1 year
Secondary Outcomes (9)
Stent Thrombosis
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
MACE
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death or MI
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
TVR
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
- +4 more secondary outcomes
Study Arms (1)
Coronary artery stenting
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.
Interventions
Coronary artery stenting with drug eluting stents
Eligibility Criteria
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.
You may qualify if:
- According to Instructions For Use
You may not qualify if:
- Contraindications according to Instructions for Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- Pharmaceutical Research Associatescollaborator
Study Sites (37)
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000, Belgium
CHU de Charleroi - ISPPC
Charleroi, 6000, Belgium
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, 8800, Belgium
CH Avignon
Avignon, 84902, France
CHU Besancon
Besançon, 25030, France
Centre Hospitalier Privé Saint Martin gds
Caen, 14000, France
CHU Grenoble
Grenoble, 38043, France
Hôpital Privé Clairval
Marseille, 13006, France
CHG de Pau
Pau, 64046, France
Clinique Saint-Hilaire Rouen
Rouen, 7600, France
Centre Hôpital Universitaire Rangueuil
Toulouse, 31059, France
Kardiocentrum Frankfurt
Frankfurt am Main, Hesse, 60316, Germany
Krankenhaus d. Barmherzigen Brüder
Trier, Rhineland-Palatinate, 76133, Germany
Klinikum Coburg gGmbH
Coburg, 96450, Germany
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, 1324, Germany
Augusta Krankenhaus
Düsseldorf, 40472, Germany
Krankenhaus Landshut-Achdorf
Landshut, 84036, Germany
Medical School of University PECS
Pécs, 7632, Hungary
Galway University Hospital
Galway, Ireland
Ospedale Ferrarotto
Catania, 95100, Italy
Ospedale Cannizzaro
Catania, 95126, Italy
Ospedale Misericordia ASL 9
Grosseto, 58100, Italy
Azienda Ospedaliera Papardo
Messina, 98161, Italy
P. Stradins University Hospital
Riga, LV-1002, Latvia
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, 05-825, Poland
Hospital General de Albacete
Albacete, 2006, Spain
Hospital Universitario de Bellvitge
Barcelona, 8907, Spain
Hospital General De Leon
León, 24008, Spain
Hospital La Paz
Madrid, 28046, Spain
H. Marques De Valdecilla
Santander, 39008, Spain
Craigavon Hospital, Southern Trust
Craigavon, Northern Ireland, BT63 5QQ, United Kingdom
Royal Bournemouth General Hospital
Bournemouth, BH7 7DW, United Kingdom
Lister
Hertfordshire, United Kingdom
London Chest Hospital
London, E2 9JX, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Norfolk and Norwich University Hospital NHS Trust
Norwich, NR4 &UY, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 25572023RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corrado Tamburino, Prof.
Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
- STUDY DIRECTOR
Peter Maurer, PhD
Boston Scientific Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2013
Study Completion
July 1, 2015
Last Updated
February 3, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
Primary endpoint data presented at TCT 2014.