Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
- Conditions
- De Novo and Re-stenosed Coronary Artery Lesions
- Interventions
- Device: Pro Kinetic Energy bare metal stent
- Registration Number
- NCT01056120
- Lead Sponsor
- Biotronik AG
- Brief Summary
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1026
- Patient signed informed consent for data release
- Patient eligible for percutaneous coronary intervention (PCI)
- De novo and re-stenosed coronary artery lesions
- Patient is geographically stable and willing to participate at all follow up assessments
- Patient is > 18 years of age
- Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
- Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
- Patient presents with ISR (in-stent restenosis)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ENERGY-Population Pro Kinetic Energy bare metal stent Patient population in standard clinical care, according to the instructions for use and the inclusion / exclusion criteria. Registry patients should be enrolled consecutively to represent a typical set of patients at each site. The registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry.
- Primary Outcome Measures
Name Time Method MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) 6 months
- Secondary Outcome Measures
Name Time Method • MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13) 6,12, 24 Months
Trial Locations
- Locations (50)
Riga East Clinical University Hospital
🇱🇻Riga, Latvia
University Hospital Zürich
🇨🇭Zürich, Switzerland
Elbe Klinikum Stade GmbH
🇩🇪Stade, Germany
Kaplan Medical Center
🇮🇱Rehovot, Israel
Clinique Rhone Durance
🇫🇷Avignon, France
Clinique Convert
🇫🇷Bourg en Bresse, France
Centre Hospitalier de Chartres
🇫🇷Chartres, France
Vinzenz Krankenhaus
🇩🇪Essen, Germany
Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
Marien-Hospital Witten GmbH
🇩🇪Witten, Germany
Alfried Krupp Klinikum Essen
🇩🇪Essen, Germany
Landeskrankenhaus Bruck an der Mur
🇦🇹Bruck an der Mur, Austria
Hospital Mexoeiro
🇪🇸Vigo, Spain
Centre Hospitalier de Pau
🇫🇷Pau, France
Vivantes Humboldt Klinikum
🇩🇪Berlin, Germany
Hospital Clinic I Provinvial de Barcelona
🇪🇸Barcelona, Spain
Städ. Klinikum Dresden- Friedrichstadt
🇩🇪Dresden, Germany
Kardinal Schwarzenberg'sches Krankenhaus
🇦🇹Schwarzach st. Veit, Austria
Cliniques Universitaires UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
Clinique la Mutualiste
🇫🇷Grenoble, France
Clinique Générale de Marignane
🇫🇷Marignane, France
Herz- und Diabeteszentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Clinique Axium
🇫🇷Aix en Provence, France
Clinique Cecil
🇨🇭Lausanne, Switzerland
Asklepios Klinikum St. Georg
🇩🇪Hamburg, Germany
Westdeutsches Herzzentrum Essen
🇩🇪Essen, NRW, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Niels-Stensen-Kliniken Marienhospital Osnabrück
🇩🇪Osnabrück, Germany
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
St. Marien Hospital
🇩🇪Lünen, Germany
Hospital de la Santa Creu i San Pau
🇪🇸Barcelona, Spain
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Carmel Medical Center
🇮🇱Haifa, Israel
Assaf Harofeh Medical Center
🇮🇱Beer Yakov, Israel
Hospital San Pedro de Alcantara
🇪🇸Caceres, Spain
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Ziv Medical Center
🇮🇱Zefat, Israel
Hospital Torrecardenas
🇪🇸Almeria, Spain
Hospital Galdakao
🇪🇸Vizcaya, Spain
Hospital de Puerta de Hierro
🇪🇸Madrid, Spain
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Klinikum Dortmund GmbH
🇩🇪Dortmund, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
🇩🇪Speyer, Germany
Clinique Saint Pierre
🇫🇷Perpignan, France
Charité-Universitätsm. Berlin Campus Charité-Mitte
🇩🇪Berlin, Germany
SRH Zentralklinikum Suhl
🇩🇪Suhl, Germany
Craigavon Cardiac Centre
🇮🇪Craigavon, Ireland