Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
NCT ID: NCT01056120
Last Updated: 2016-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1026 participants
OBSERVATIONAL
2010-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ENERGY-Population
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.
Pro Kinetic Energy bare metal stent
PCI
Interventions
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Pro Kinetic Energy bare metal stent
PCI
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Raimund Erbel, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
Locations
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Landeskrankenhaus Bruck an der Mur
Bruck an der Mur, , Austria
Kardinal Schwarzenberg'sches Krankenhaus
Schwarzach Saint Veit, , Austria
Saint-Pierre University Hospital
Brussels, , Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, , Belgium
Clinique Axium
Aix-en-Provence, , France
Clinique Rhone Durance
Avignon, , France
Clinique Convert
Bourg-en-Bresse, , France
Centre Hospitalier de Chartres
Chartres, , France
Clinique la Mutualiste
Grenoble, , France
Clinique Générale de Marignane
Marignane, , France
Centre Hospitalier de Pau
Pau, , France
Clinique Saint Pierre
Perpignan, , France
Westdeutsches Herzzentrum Essen
Essen, North Rhine-Westphalia, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, , Germany
Charité-Universitätsm. Berlin Campus Charité-Mitte
Berlin, , Germany
Vivantes Humboldt Klinikum
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Dortmund GmbH
Dortmund, , Germany
Städ. Klinikum Dresden- Friedrichstadt
Dresden, , Germany
Alfried Krupp Klinikum Essen
Essen, , Germany
Vinzenz Krankenhaus
Essen, , Germany
Asklepios Klinikum St. Georg
Hamburg, , Germany
St. Marien Hospital
Lünen, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, , Germany
Elbe Klinikum Stade GmbH
Stade, , Germany
SRH Zentralklinikum Suhl
Suhl, , Germany
Marien-Hospital Witten GmbH
Witten, , Germany
Craigavon Cardiac Centre
Craigavon, , Ireland
Assaf Harofeh Medical Center
Beer Yakov, , Israel
Carmel Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Kaplan Medical Center
Rehovot, , Israel
Ziv Medical Center
Safed, , Israel
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
VU Medisch Centrum
Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Hospital Torrecardenas
Almería, , Spain
Hospital Clinic I Provinvial de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i San Pau
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital de Puerta de Hierro
Madrid, , Spain
Hospital Mexoeiro
Vigo, , Spain
Hospital Galdakao
Vizcaya, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Clinique Cecil
Lausanne, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
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References
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Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.
Erbel R, Eggebrecht H, Roguin A, Schroeder E, Philipp S, Heitzer T, Schwacke H, Ayzenberg O, Serra A, Delarche N, Luchner A, Slagboom T; ENERGY Investigators. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry. Cardiovasc Revasc Med. 2014 Nov-Dec;15(8):381-7. doi: 10.1016/j.carrev.2014.10.002. Epub 2014 Oct 15.
Other Identifiers
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C0903
Identifier Type: -
Identifier Source: org_study_id
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