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

Boston Scientific

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Procedure: Coronary artery stenting

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01242696

S2059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,014 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to Instructions For Use

Exclusion criteria

• Contraindications according to Instructions for Use

Trial design

1,014 participants in 1 patient group

Coronary artery stenting

Description:

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.

Treatment:

Procedure: Coronary artery stenting