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

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT01242696
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Primary Completion: 2013-03
• Study Completion: 2015-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1014

Inclusion Criteria

• According to Instructions For Use

Exclusion Criteria

• Contraindications according to Instructions for Use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Vessel failure	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

Name	Time	Method
Stent Thrombosis	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)).
MI	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	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation	All Death rates
Cardiac Death or MI	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
Non-Cardiac Death	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation	Non-Cardiac Death rates
All Death or MI	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation	All Death or MI rates
Cardiac Death	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
MACE	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).
TVR	30 days, 6 months, 12 months and then annually through 3 years post index stent implantation	Overall and TAXUS Element stent-related TVR rates

Trial Locations

Locations (37)

Algemeen Ziekenhuis Sint-Jan; 🇧🇪 Brugge, Belgium

CHU de Charleroi - ISPPC; 🇧🇪 Charleroi, Belgium

H-Hartziekenhuis Roeselare-Menen vzw; 🇧🇪 Roeselare, Belgium

CH Avignon; 🇫🇷 Avignon, France

CHU Besancon; 🇫🇷 Besancon, France

Centre Hospitalier Privé Saint Martin gds; 🇫🇷 Caen, France

CHU Grenoble; 🇫🇷 Grenoble, France

Hôpital Privé Clairval; 🇫🇷 Marseille, France

CHG de Pau; 🇫🇷 Pau, France

Clinique Saint-Hilaire Rouen; 🇫🇷 Rouen, France

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