PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT01148329
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1010
- According to Instructions For Use
- Contraindications according to Instructions for Use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Vessel Failure (TVF) One year 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.
- Secondary Outcome Measures
Name Time Method Death or MI rates 30 days, 6 months, 12 months and then annually through 5 years Overall and PROMUS™ Element™ stent-related cardiac death or MI rates
Cardiac death rates 30 days, 6 months, 12 months and then annually through 5 years Overall and PROMUS™ Element™ stent-related cardiac death rates.
TVR rates 30 days, 6 months, 12 months and then annually through 5 years Overall and PROMUS™ Element™ stent-related TVR rates.
MI Rates 30 days, 6 months, 12 months and then annually through 5 years Overall and PROMUS™ Element™ stent-related MI rates.
All death rates 30 days, 6 months, 12 months and then annually through 5 years All death rates
Non-cardiac death rates 30 days, 6 months, 12 months and then annually through 5 years Non-cardiac death rates
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) 30 days, 6 months, 12 months and then annually through 5 years Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR).
All death or MI rates 30 days, 6 months, 12 months and then annually through 5 years All death and MI rates
Trial Locations
- Locations (40)
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
🇧🇪Liege, 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
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