TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study (TE-Prove)
- Conditions
- Coronary Heart Disease
- Interventions
- Procedure: Coronary artery stenting
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1014
- According to Instructions For Use
- Contraindications according to Instructions for Use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Coronary artery stenting 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.
- 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
H-Hartziekenhuis Roeselare-Menen vzw
🇧🇪Roeselare, Belgium
CHU Grenoble
🇫🇷Grenoble, France
Hôpital Privé Clairval
🇫🇷Marseille, France
CHU Besancon
🇫🇷Besancon, France
CH Avignon
🇫🇷Avignon, France
Centre Hospitalier Privé Saint Martin gds
🇫🇷Caen, France
CHG de Pau
🇫🇷Pau, France
Clinique Saint-Hilaire Rouen
🇫🇷Rouen, France
Centre Hôpital Universitaire Rangueuil
🇫🇷Toulouse, France
Klinikum Coburg gGmbH
🇩🇪Coburg, Germany
Kardiocentrum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Germany
Augusta Krankenhaus
🇩🇪Dusseldorf, Germany
Krankenhaus Landshut-Achdorf
🇩🇪Landshut, Germany
Medical School of University PECS
🇭🇺Pecs, Hungary
Ospedale Ferrarotto
🇮🇹Catania, Italy
Ospedale Misericordia ASL 9
🇮🇹Grosseto, Italy
Azienda Ospedaliera Papardo
🇮🇹Messina, Italy
Hospital La Paz
🇪🇸Madrid, Spain
P. Stradins University Hospital
🇱🇻Riga, Latvia
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II
🇵🇱Grodzisk Mazowiecki, Poland
Hospital General de Albacete
🇪🇸Albacete, Spain
H. Marques De Valdecilla
🇪🇸Santander, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Lister
🇬🇧Hertfordshire, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon -Tyne, United Kingdom
Royal Bournemouth General Hospital
🇬🇧Bournemouth, United Kingdom
London Chest Hospital
🇬🇧London, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Norfolk and Norwich University Hospital NHS Trust
🇬🇧Norwich, United Kingdom
Hospital General De Leon
🇪🇸León, Spain
Ospedale Cannizzaro
🇮🇹Catania, Italy
Krankenhaus d. Barmherzigen Brüder
🇩🇪Trier, Rheinland Pfalz, Germany
Craigavon Hospital, Southern Trust
🇬🇧Craigavon, Northern Ireland, United Kingdom
Galway University Hospital
🇮🇪Galway, Ireland
CHU de Charleroi - ISPPC
🇧🇪Charleroi, Belgium