TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)

NCT ID: NCT01242696

Last Updated: 2017-02-03

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

COMPLETED

Total Enrollment

1014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Coronary artery stenting

Intervention Type PROCEDURE

Coronary artery stenting with drug eluting stents

Interventions

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Coronary artery stenting

Coronary artery stenting with drug eluting stents

Intervention Type PROCEDURE

Other Intervention Names

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TAXUS Element

Eligibility Criteria

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Inclusion Criteria

* According to Instructions For Use

Exclusion Criteria

* Contraindications according to Instructions for Use
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research Associates

OTHER

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corrado Tamburino, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy

Peter Maurer, PhD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Algemeen Ziekenhuis Sint-Jan

Bruges, , Belgium

Site Status

CHU de Charleroi - ISPPC

Charleroi, , Belgium

Site Status

H-Hartziekenhuis Roeselare-Menen vzw

Roeselare, , Belgium

Site Status

CH Avignon

Avignon, , France

Site Status

CHU Besancon

Besançon, , France

Site Status

Centre Hospitalier Privé Saint Martin gds

Caen, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

Hôpital Privé Clairval

Marseille, , France

Site Status

CHG de Pau

Pau, , France

Site Status

Clinique Saint-Hilaire Rouen

Rouen, , France

Site Status

Centre Hôpital Universitaire Rangueuil

Toulouse, , France

Site Status

Kardiocentrum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Krankenhaus d. Barmherzigen Brüder

Trier, Rhineland-Palatinate, Germany

Site Status

Klinikum Coburg gGmbH

Coburg, , Germany

Site Status

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, , Germany

Site Status

Augusta Krankenhaus

Düsseldorf, , Germany

Site Status

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Site Status

Medical School of University PECS

Pécs, , Hungary

Site Status

Galway University Hospital

Galway, , Ireland

Site Status

Ospedale Ferrarotto

Catania, , Italy

Site Status

Ospedale Cannizzaro

Catania, , Italy

Site Status

Ospedale Misericordia ASL 9

Grosseto, , Italy

Site Status

Azienda Ospedaliera Papardo

Messina, , Italy

Site Status

P. Stradins University Hospital

Riga, , Latvia

Site Status

Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

Grodzisk Mazowiecki, , Poland

Site Status

Hospital General de Albacete

Albacete, , Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital General De Leon

León, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

H. Marques De Valdecilla

Santander, , Spain

Site Status

Craigavon Hospital, Southern Trust

Craigavon, Northern Ireland, United Kingdom

Site Status

Royal Bournemouth General Hospital

Bournemouth, , United Kingdom

Site Status

Lister

Hertfordshire, , United Kingdom

Site Status

London Chest Hospital

London, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Norfolk and Norwich University Hospital NHS Trust

Norwich, , United Kingdom

Site Status

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

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Belgium France Germany Hungary Ireland Italy Latvia Poland Spain United Kingdom

References

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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.

Reference Type RESULT
PMID: 25572023 (View on PubMed)

Other Identifiers

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S2059

Identifier Type: -

Identifier Source: org_study_id

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