AzTrials
AzTrials

Coronary Heart DiseaseTE-ProveNCT01242696

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

An observational study of Coronary Heart Disease, run by Boston Scientific Corporation at 37 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Heart Disease
What is being tested?
Coronary artery stenting
Type of treatment
Surgery or procedure
How many people
1,014 participants
Where
37 sitesin 10 countries
Study dates
Nov 2010to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • According to Instructions For Use

Who cannot join

  • Contraindications according to Instructions for Use

Trial locations and contacts

37 sites in 10 countries.

37 sites in 10 countries

France8 sites

  • CH Avignon

    Avignon, 84902

  • CHU Besancon

    Besançon, 25030

  • Centre Hospitalier Privé Saint Martin gds

    Caen, 14000

  • CHU Grenoble

    Grenoble, 38043

  • Hôpital Privé Clairval

    Marseille, 13006

  • CHG de Pau

    Pau, 64046

  • Clinique Saint-Hilaire Rouen

    Rouen, 7600

  • Centre Hôpital Universitaire Rangueuil

    Toulouse, 31059

Other trials in France

United Kingdom7 sites

  • Royal Bournemouth General Hospital

    Bournemouth, BH7 7DW

  • Craigavon Hospital, Southern Trust

    Craigavon, Northern Ireland, BT63 5QQ

  • Lister

    Hertfordshire

  • London Chest Hospital

    London, E2 9JX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Norfolk and Norwich University Hospital NHS Trust

    Norwich, NR4 &UY

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany6 sites

  • Klinikum Coburg gGmbH

    Coburg, 96450

  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

    Dresden, 1324

  • Augusta Krankenhaus

    Düsseldorf, 40472

  • Kardiocentrum Frankfurt

    Frankfurt am Main, Hesse, 60316

  • Krankenhaus Landshut-Achdorf

    Landshut, 84036

  • Krankenhaus d. Barmherzigen Brüder

    Trier, Rhineland-Palatinate, 76133

Other trials in Germany

Spain5 sites

  • Hospital General de Albacete

    Albacete, 2006

  • Hospital Universitario de Bellvitge

    Barcelona, 8907

  • Hospital General De Leon

    León, 24008

  • Hospital La Paz

    Madrid, 28046

  • H. Marques De Valdecilla

    Santander, 39008

Other trials in Spain

Italy4 sites

  • Ospedale Ferrarotto

    Catania, 95100

  • Ospedale Cannizzaro

    Catania, 95126

  • Ospedale Misericordia ASL 9

    Grosseto, 58100

  • Azienda Ospedaliera Papardo

    Messina, 98161

Other trials in Italy

Belgium3 sites

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000

  • CHU de Charleroi - ISPPC

    Charleroi, 6000

  • H-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Hungary1 site

  • Medical School of University PECS

    Pécs, 7632

Other trials in Hungary

Ireland1 site

  • Galway University Hospital

    Galway

Other trials in Ireland

Latvia1 site

  • P. Stradins University Hospital

    Riga, LV-1002

Other trials in Latvia

Poland1 site

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

    Grodzisk Mazowiecki, 05-825

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Coronary artery stenting
Keywords
Drug Eluting Stents, Observational, All-Comers
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery stentingProcedure or surgery

    Also called TAXUS Element

    Coronary artery stenting with drug eluting stents

Study groups in NCT01242696
Study groupRoleWhat they receive
Coronary artery stentingAll 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.
Receives: Procedure: Coronary artery stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (9)

  1. Stent Thrombosis

    Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)).

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  2. MACE

    Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR).

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  3. Cardiac Death or MI

    Overall and TAXUS Element stent-related cardiac death or MI rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  4. TVR

    Overall and TAXUS Element stent-related TVR rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  5. Cardiac Death

    Overall and TAXUS Element stent-related cardiac death rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  6. MI

    Overall and TAXUS Element stent-related MI rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  7. All Death

    All Death rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  8. Non-Cardiac Death

    Non-Cardiac Death rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

  9. All Death or MI

    All Death or MI rates

    Measured: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2013
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01242696
Sponsor's protocol ID
S2059
Acronym
TE-Prove
Status last verified
Feb 2017
First submitted
16 Nov 2010
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Primary endpoint data presented at TCT 2014.

Publications

  • 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.

    PubMed 25572023

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by Boston Scientific Corporation at 37 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France, United Kingdom, Germany, Spain, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel failure (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01242696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in