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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014