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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242696
First Posted: November 17, 2010
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pharmaceutical Research Associates
Information provided by (Responsible Party):
Boston Scientific Corporation
  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 ]
    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 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)).

  • 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).

  • 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

  • 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

  • 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

  • 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

  • All Death [ Time Frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation ]
    All Death rates

  • 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

  • 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


Enrollment: 1014
Study Start Date: November 2010
Study Completion Date: July 2015
Primary Completion Date: March 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242696


  Show 37 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Pharmaceutical Research Associates
Investigators
Principal Investigator: Corrado Tamburino, Prof. Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
Study Director: Peter Maurer, PhD Boston Scientific Corporation
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01242696     History of Changes
Other Study ID Numbers: S2059
First Submitted: November 16, 2010
First Posted: November 17, 2010
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Primary endpoint data presented at TCT 2014.

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

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