The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
Study Type
OBSERVATIONAL
Enrollment
1,010
The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.
Target Vessel Failure (TVF)
Overall and PROMUS™ Element™ stent related 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: One year
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)
Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Death or MI rates
Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
TVR rates
Overall and PROMUS™ Element™ stent-related TVR rates.
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Cardiac death rates
Overall and PROMUS™ Element™ stent-related cardiac death rates.
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
MI Rates
Overall and PROMUS™ Element™ stent-related MI rates.
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
All death rates
All death rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
Non-cardiac death rates
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Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
Medizinische Universität Wien
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
Virga Jesse Ziekenhuis
Hasselt, Belgium
Centre Hôpital Universitaire Sart Tilman
Liège, Belgium
Odense University Hospital
Odense, Denmark
Roskilde Sygehus
Roskilde, Denmark
Centre Hospitalier Privé Saint Martin gds
Caen, France
Le Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
Polyclinique les Fleurs
Ollioules, France
...and 30 more locations
Non-cardiac death rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years
All death or MI rates
All death and MI rates
Time frame: 30 days, 6 months, 12 months and then annually through 5 years