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

February 2, 2017 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1014

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis Sint-Jan
      • Charleroi, Belgium, 6000
        • CHU de Charleroi - ISPPC
      • Roeselare, Belgium, 8800
        • H-Hartziekenhuis Roeselare-Menen vzw
  • France
      • Avignon, France, 84902
        • Ch Avignon
      • Besancon, France, 25030
        • CHU Besançon
      • Caen, France, 14000
        • Centre Hospitalier Privé Saint Martin gds
      • Grenoble, France, 38043
        • CHU Grenoble
      • Marseille, France, 13006
        • Hopital Prive Clairval
      • Pau, France, 64046
        • CHG de Pau
      • Rouen, France, 7600
        • Clinique Saint-Hilaire Rouen
      • Toulouse, France, 31059
        • Centre Hôpital Universitaire Rangueuil
  • Germany
      • Coburg, Germany, 96450
        • Klinikum Coburg gGmbH
      • Dresden, Germany, 1324
        • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
      • Dusseldorf, Germany, 40472
        • Augusta Krankenhaus
      • Landshut, Germany, 84036
        • Krankenhaus Landshut-Achdorf
    • Hessen
      • Frankfurt, Hessen, Germany, 60316
        • Kardiocentrum Frankfurt
    • Rheinland Pfalz
      • Trier, Rheinland Pfalz, Germany, 76133
        • Krankenhaus d. Barmherzigen Brüder
  • Hungary
      • Pecs, Hungary, 7632
        • Medical School of University PECS
  • Ireland
      • Galway, Ireland
        • Galway University Hospital
  • Italy
      • Catania, Italy, 95100
        • Ospedale Ferrarotto
      • Catania, Italy, 95126
        • Ospedale Cannizzaro
      • Grosseto, Italy, 58100
        • Ospedale Misericordia ASL 9
      • Messina, Italy, 98161
        • Azienda Ospedaliera Papardo
  • Latvia
      • Riga, Latvia, LV-1002
        • P. Stradins University Hospital
  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
  • Spain
      • Albacete, Spain, 2006
        • Hospital General de Albacete
      • Barcelona, Spain, 8907
        • Hospital Universitario de Bellvitge
      • León, Spain, 24008
        • Hospital General de Leon
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Santander, Spain, 39008
        • H. Marques De Valdecilla
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital
      • Hertfordshire, United Kingdom
        • Lister
      • London, United Kingdom, E2 9JX
        • London Chest Hospital
      • Newcastle upon -Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Norwich, United Kingdom, NR4 &UY
        • Norfolk and Norwich University Hospital NHS Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
    • Northern Ireland
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Craigavon Hospital, Southern Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Coronary artery stenting
Coronary artery stenting with drug eluting stents
Other Names:
  • TAXUS Element

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel failure
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent Thrombosis
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)).
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
MACE
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR).
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death or MI
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Overall and TAXUS Element stent-related cardiac death or MI rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
TVR
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Overall and TAXUS Element stent-related TVR rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Overall and TAXUS Element stent-related cardiac death rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
MI
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Overall and TAXUS Element stent-related MI rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Non-Cardiac Death
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Non-Cardiac Death rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death or MI
Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death or MI rates
30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Pharmaceutical Research Associates

Investigators

  • Principal Investigator: Corrado Tamburino, Prof., Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
  • Study Director: Peter Maurer, PhD, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Primary endpoint data presented at TCT 2014.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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