Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01056120
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2010-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1026}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['De Novo and Re-stenosed Coronary Artery Lesions']}, 'referencesModule': {'references': [{'pmid': '25775674', 'type': 'DERIVED', '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.'}, {'pmid': '25456414', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient signed informed consent for data release\n* Patient eligible for percutaneous coronary intervention (PCI)\n* De novo and re-stenosed coronary artery lesions\n* Patient is geographically stable and willing to participate at all follow up assessments\n* Patient is \\> 18 years of age\n\nExclusion Criteria:\n\n* Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel\n* Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI\n* Patient presents with ISR (in-stent restenosis)'}, 'identificationModule': {'nctId': 'NCT01056120', 'acronym': 'ENERGY', 'briefTitle': 'Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'C0903'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ENERGY-Population', 'description': '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.\n\nThe registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry.', 'interventionNames': ['Device: Pro Kinetic Energy bare metal stent']}], 'interventions': [{'name': 'Pro Kinetic Energy bare metal stent', 'type': 'DEVICE', 'description': 'PCI', 'armGroupLabels': ['ENERGY-Population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bruck an der Mur', 'country': 'Austria', 'facility': 'Landeskrankenhaus Bruck an der Mur', 'geoPoint': {'lat': 47.41667, 'lon': 15.28333}}, {'city': 'Schwarzach Saint Veit', 'country': 'Austria', 'facility': "Kardinal Schwarzenberg'sches Krankenhaus"}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Saint-Pierre University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Cliniques Universitaires UCL de Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhone Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Clinique Convert', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'city': 'Chartres', 'country': 'France', 'facility': 'Centre Hospitalier de Chartres', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Clinique la Mutualiste', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Marignane', 'country': 'France', 'facility': 'Clinique Générale de Marignane', 'geoPoint': {'lat': 43.41727, 'lon': 5.21462}}, {'city': 'Pau', 'country': 'France', 'facility': 'Centre Hospitalier de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'city': 'Perpignan', 'country': 'France', 'facility': 'Clinique Saint Pierre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Westdeutsches Herzzentrum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum Nordrhein-Westfalen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsm. Berlin Campus Charité-Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Humboldt Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Klinikum Dortmund GmbH', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Städ. Klinikum Dresden- Friedrichstadt', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Alfried Krupp Klinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Vinzenz Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinikum St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Lünen', 'country': 'Germany', 'facility': 'St. Marien Hospital', 'geoPoint': {'lat': 51.61634, 'lon': 7.52872}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Niels-Stensen-Kliniken Marienhospital Osnabrück', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Speyer', 'country': 'Germany', 'facility': 'Diakonissen-Stiftungs-Krankenhaus Speyer', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}, {'city': 'Stade', 'country': 'Germany', 'facility': 'Elbe Klinikum Stade GmbH', 'geoPoint': {'lat': 53.59407, 'lon': 9.47302}}, {'city': 'Suhl', 'country': 'Germany', 'facility': 'SRH Zentralklinikum Suhl', 'geoPoint': {'lat': 50.60911, 'lon': 10.69401}}, {'city': 'Witten', 'country': 'Germany', 'facility': 'Marien-Hospital Witten GmbH', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}, {'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', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Pauls Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Riga East Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Almería', 'country': 'Spain', 'facility': 'Hospital Torrecardenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provinvial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i San Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital San Pedro de Alcantara', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Mexoeiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital Galdakao'}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Clinique Cecil', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Raimund Erbel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kardiologie Westdeutsches Herzzentrum Essen, Universitätsklinikum Essen, Hufelandstrasse 55, D-45122 Essen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}