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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharmaceutical Research Associates, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01242696
First received: November 16, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Procedure: Coronary artery stenting

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Vessel failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Stent Thrombosis [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)).

  • MACE [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR).

  • Cardiac Death or MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related cardiac death or MI rates

  • TVR [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related TVR rates

  • Cardiac Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related cardiac death rates

  • MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Overall and TAXUS Element stent-related MI rates

  • All Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    All Death rates

  • Non-Cardiac Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    Non-Cardiac Death rates

  • All Death or MI [ Time Frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation ] [ Designated as safety issue: Yes ]
    All Death or MI rates


Enrollment: 1014
Study Start Date: November 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: TAXUS Element

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242696

  Show 42 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Pharmaceutical Research Associates, Inc.
Investigators
Principal Investigator: Corrado Tamburino, Prof. Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01242696     History of Changes
Other Study ID Numbers: S2059
Study First Received: November 16, 2010
Last Updated: December 19, 2013
Health Authority: Belgium: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Italy: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Drug Eluting Stents
Observational
All-Comers

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014