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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hôpital Privé 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. Marqués 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmaceutical Research Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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