PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Coronary stenting
- 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
- Arm && Interventions
Group Intervention Description Single arm observational study Coronary stenting To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice
- 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)
Dept. of Internal Medicine and Cardiological Center
🇭🇺Szeged, Hungary
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Beaumont Hospital
🇮🇪Dublin, Ireland
Medizinische Universität Wien
🇦🇹Vienna, Austria
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Virga Jesse Ziekenhuis
🇧🇪Hasselt, Belgium
Le Centre Chirurgical Marie Lannelongue
🇫🇷Le Plessis Robinson, France
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
Schwarzwald Baar Klinikum Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Allgemeines Krankenhaus der Stadt Linz
🇦🇹Linz, Austria
Odense University Hospital
🇩🇰Odense, Denmark
IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Klinikum Leverkusen
🇩🇪Leverkusen, NRW, Germany
Med. Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, NRW, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, NRW, Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Centre Hospitalier Privé Saint Martin gds
🇫🇷Caen, France
Freeman, Newcastle-Upon-Tyne
🇬🇧Newcastle-Upon-Tyne, United Kingdom
Centre Hôpital Universitaire Sart Tilman
🇧🇪Liege, Belgium
St. James's Hospital
🇮🇪Dublin, Ireland
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Clinica Mediterranea
🇮🇹Napoli, Italy
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain
Roskilde Sygehus
🇩🇰Roskilde, Denmark
Polyclinique les Fleurs
🇫🇷Ollioules, France
Clinique St. Martin
🇫🇷Pessac, France
Clinique Saint-Hilaire Rouen
🇫🇷Rouen, France
Clinique Pasteur
🇫🇷Toulouse, France
Galway University Hospital
🇮🇪Galway, Ireland
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
King's College Hospital London
🇬🇧London, United Kingdom
St. Thomas Hospital
🇬🇧London, United Kingdom