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NCT Number: NCT01242696

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Ziekenhuis Sint-Jan, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • According to Instructions For Use

Exclusion criteria

  • Contraindications according to Instructions for Use

Treatment and study plan

Coronary artery stenting

Procedure

Coronary artery stenting with drug eluting stents

Other names: TAXUS Element

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)).

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. All Death

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

    All Death rates

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Pharmaceutical Research Associates

Registry information

Official study 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

Acronym: TE-Prove

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Nov 17, 2010
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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