De Novo and Re-stenosed Coronary Artery Lesions Clinical Trial
— ENERGYOfficial 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
| Verified date | January 2016 |
| Source | Biotronik AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1026 |
| Est. completion date | December 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Landeskrankenhaus Bruck an der Mur | Bruck an der Mur | |
| Austria | Kardinal Schwarzenberg'sches Krankenhaus | Schwarzach st. Veit | |
| Belgium | Saint-Pierre University Hospital | Brussels | |
| Belgium | Cliniques Universitaires UCL de Mont-Godinne | Yvoir | |
| France | 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 | |
| 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 | Westdeutsches Herzzentrum Essen | Essen | NRW |
| 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 | |
| Ireland | Craigavon Cardiac Centre | Craigavon | |
| Israel | 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 | |
| Latvia | Pauls Stradins Clinical University Hospital | Riga | |
| Latvia | Riga East Clinical University Hospital | Riga | |
| Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
| Netherlands | VU Medisch Centrum | Amsterdam | |
| Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
| Spain | 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 | |
| Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
| Switzerland | Clinique Cecil | Lausanne | |
| Switzerland | University Hospital Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Biotronik AG |
Austria, Belgium, France, Germany, Ireland, Israel, Latvia, Netherlands, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) | 6 months | Yes | |
| Secondary | • 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 | Yes |