Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01197651
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic-Stent-Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '◦Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine', 'timeFrame': 'Hospital-stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aorta', 'Aorta-Stent-Graft', 'Surgical operation', 'Aortic dissection'], 'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'The aims of the aorta-stent-Registry are:\n\n• participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:', 'detailedDescription': '1. Endovascular Aorta-Stent-Graft\n2. Surgical operation of the distal thoracal aorta\n\n * Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.\n * Documentation of the operational risk (Euroscore)\n * Documentation of the technical enforcement of the procedure as well as the result of the intervention\n * Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)\n * Documentation of medication at hospital discharge\n * Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \\& 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients being treated in one of the participating hospitals because of a disease of the distal thoracal aorta', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with significant illness of the distal thoracal aorta (distal Aortic-dissection; TAA; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation.\n\nExclusion Criteria:\n\n* Missing signed informed consent'}, 'identificationModule': {'nctId': 'NCT01197651', 'briefTitle': 'Aortic-Stent-Register', 'organization': {'class': 'OTHER', 'fullName': 'Stiftung Institut fuer Herzinfarktforschung'}, 'officialTitle': 'Aortenstent-Register Thorakale Aorta', 'orgStudyIdInfo': {'id': 'Aortenstent'}}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herz-Zentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik GmbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '45123', 'city': 'Essen', 'country': 'Germany', 'facility': 'Westdeutsches Herzzentrum Essen, Uniklinikum', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '81737', 'city': 'München', 'country': 'Germany', 'facility': 'Städt. Klinikum München GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsklinikum Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Raimund Erbel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Westdeutsches Herzzentrum Essen'}, {'name': 'Holger Eggebrecht, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Westdeutsches Herzzentrum Essen'}, {'name': 'Thomas Helmberger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Bogenhausen'}, {'name': 'Christoph Nienaber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Rostock'}, {'name': 'Hüseyin Ince, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Rostock'}, {'name': 'Harald Mudra, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Neuperlach'}, {'name': 'Ralf Zahn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Ludwigshafen'}, {'name': 'Jochen Senges, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}