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.
Study Type
OBSERVATIONAL
Enrollment
1,014
Coronary artery stenting with drug eluting stents
Target Vessel failure
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
Time frame: 1 year
Stent Thrombosis
Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)).
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
MACE
Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR).
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death or MI
Overall and TAXUS Element stent-related cardiac death or MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
TVR
Overall and TAXUS Element stent-related TVR rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Cardiac Death
Overall and TAXUS Element stent-related cardiac death rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
MI
Overall and TAXUS Element stent-related MI rates
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium
CHU de Charleroi - ISPPC
Charleroi, Belgium
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium
CH Avignon
Avignon, France
CHU Besancon
Besançon, 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
...and 27 more locations
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death
All Death rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
Non-Cardiac Death
Non-Cardiac Death rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation
All Death or MI
All Death or MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation