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

November 16, 2010
December 19, 2013
November 2010
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01242696 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Coronary Heart Disease
Procedure: Coronary artery stenting
Coronary artery stenting with drug eluting stents
Other Name: TAXUS Element
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.
Intervention: Procedure: Coronary artery stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1014
July 2017
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • According to Instructions For Use

Exclusion Criteria:

  • Contraindications according to Instructions for Use
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Hungary,   Ireland,   Italy,   Latvia,   Poland,   Spain,   United Kingdom
 
NCT01242696
S2059
No
Boston Scientific Corporation
Boston Scientific Corporation
Pharmaceutical Research Associates, Inc.
Principal Investigator: Corrado Tamburino, Prof. Ospedale Ferrarotto, Via Citelli, 1, 95100 Catania, Italy
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
Boston Scientific Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP