Overview

This trial is active, not recruiting.

Condition coronary heart disease
Treatment coronary artery stenting
Sponsor Boston Scientific Corporation
Collaborator Pharmaceutical Research Associates, Inc.
Start date November 2010
End date March 2014
Trial size 1014 participants
Trial identifier NCT01242696, S2059

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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 artery stenting TAXUS Element
Coronary artery stenting with drug eluting stents

Primary Outcomes

Measure
Target Vessel failure
time frame: 1 year

Secondary Outcomes

Measure
Stent Thrombosis
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
MACE
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
Cardiac Death or MI
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
TVR
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
Cardiac Death
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
MI
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
All Death
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
Non-Cardiac Death
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation
All Death or MI
time frame: 30 days, 6 months, 12 months and then annually through 5 years post index stent implantation

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - According to Instructions For Use Exclusion Criteria: - Contraindications according to Instructions for Use

Additional Information

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
Principal investigator Corrado Tamburino, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.