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Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice (ENERGY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056120
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : February 1, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
De Novo and Re-stenosed Coronary Artery Lesions Device: Pro Kinetic Energy bare metal stent

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Study Type : Observational
Actual Enrollment : 1026 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial
Study Start Date : March 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment

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.

Device: Pro Kinetic Energy bare metal stent

Primary Outcome Measures :
  1. MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. • 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) [ Time Frame: 6,12, 24 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056120

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Landeskrankenhaus Bruck an der Mur
Bruck an der Mur, Austria
Kardinal Schwarzenberg'sches Krankenhaus
Schwarzach st. 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, NRW, Germany, 45122
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
Zefat, 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
Almeria, Spain
Hospital Clinic I Provinvial de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i San Pau
Barcelona, Spain
Hospital San Pedro de Alcantara
Caceres, 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
Zürich, Switzerland
Sponsors and Collaborators
Biotronik AG
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Principal Investigator: Raimund Erbel, MD Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biotronik AG Identifier: NCT01056120    
Other Study ID Numbers: C0903
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016