Clinical trial NCT01056120: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: De Novo and Re-stenosed Coronary Artery Lesions
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


Eligibility criteria: 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)

Primary outcomes:
measure: MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)
timeFrame: 6 months
Secondary outcomes:
measure: • 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)
timeFrame: 6,12, 24 Months
Other outcomes:
Locations:
city: Bruck an der Mur
country: Austria
facility: Landeskrankenhaus Bruck an der Mur
city: Schwarzach st. Veit
country: Austria
facility: Kardinal Schwarzenberg'sches Krankenhaus
city: Brussels
country: Belgium
facility: Saint-Pierre University Hospital
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
city: Aix en Provence
country: France
facility: Clinique Axium
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Bourg en Bresse
country: France
facility: Clinique Convert
city: Chartres
country: France
facility: Centre Hospitalier de Chartres
city: Grenoble
country: France
facility: Clinique la Mutualiste
city: Marignane
country: France
facility: Clinique Générale de Marignane
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perpignan
country: France
facility: Clinique Saint Pierre
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen
state: NRW
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité-Universitätsm. Berlin Campus Charité-Mitte
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dortmund
country: Germany
facility: Klinikum Dortmund GmbH
city: Dresden
country: Germany
facility: Städ. Klinikum Dresden- Friedrichstadt
city: Essen
country: Germany
facility: Alfried Krupp Klinikum Essen
city: Essen
country: Germany
facility: Vinzenz Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Klinikum St. Georg
city: Lünen
country: Germany
facility: St. Marien Hospital
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Speyer
country: Germany
facility: Diakonissen-Stiftungs-Krankenhaus Speyer
city: Stade
country: Germany
facility: Elbe Klinikum Stade GmbH
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
city: Witten
country: Germany
facility: Marien-Hospital Witten GmbH
city: Craigavon
country: Ireland
facility: Craigavon Cardiac Centre
city: Beer Yakov
country: Israel
facility: Assaf Harofeh Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Zefat
country: Israel
facility: Ziv Medical Center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Almeria
country: Spain
facility: Hospital Torrecardenas
city: Barcelona
country: Spain
facility: Hospital Clinic I Provinvial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i San Pau
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital de Puerta de Hierro
city: Vigo
country: Spain
facility: Hospital Mexoeiro
city: Vizcaya
country: Spain
facility: Hospital Galdakao
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Lausanne
country: Switzerland
facility: Clinique Cecil
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany
name: Raimund Erbel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.