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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro Kinetic Energy bare metal stent | Device | PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| • 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Raimund Erbel, MD | Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Bruck an der Mur | Bruck an der Mur | Austria | ||||
| Kardinal Schwarzenberg'sches Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25775674 | Derived | 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. | |
| 25456414 | Derived | 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. |
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| 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 | 45122 | 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 |