Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 6:48 AM
Study NCT ID:
NCT01415804
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019736', 'term': 'Prostheses and Implants'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-11', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '5 years post randomization'}], 'secondaryOutcomes': [{'measure': 'Aorta-specific mortality', 'timeFrame': '5 years post randomization'}, {'measure': 'Progression of disease', 'timeFrame': '5 years'}, {'measure': 'Aortic remodeling', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dissection', 'Aorta', 'Surgery'], 'conditions': ['Aortic Dissection']}, 'referencesModule': {'references': [{'pmid': '15990739', 'type': 'BACKGROUND', 'citation': 'Nienaber CA, Zannetti S, Barbieri B, Kische S, Schareck W, Rehders TC; INSTEAD study collaborators. INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial. Am Heart J. 2005 Apr;149(4):592-9. doi: 10.1016/j.ahj.2004.05.060.'}, {'pmid': '19996018', 'type': 'RESULT', 'citation': 'Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.'}, {'pmid': '23922146', 'type': 'DERIVED', 'citation': 'Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.', 'detailedDescription': 'Patients \\> 18 years with type B aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only stable patients without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. Long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No contraindication the general anesthesia and ventilation\n* Type B aortic dissection that occurred 2-52 weeks prior to randomization\n* Diameter of the targeted aortic segment \\< 6 cm\n* Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form\n* Availability for appropriate follow-up visits during the F/U period of 5 years\n* Capability to follow all study requirements\n\nExclusion Criteria:\n\n* Pregnancy\n* Thrombocytopenia\n* Ongoing anticoagulation therapy\n* Renal failure and/or creatinine \\> 2,4 mg%\n* Complete thrombosis of false lumen\n* Cancer likely to cause death within 1 year\n* Enrollment in another clinical study\n* Unwillingness to cooperate with study procedures or F/U visits'}, 'identificationModule': {'nctId': 'NCT01415804', 'acronym': 'INSTEAD', 'briefTitle': 'Investigation of Stent-grafts in Aortic Dissection (INSTEAD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rostock'}, 'officialTitle': 'A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial', 'orgStudyIdInfo': {'id': 'NCT00525356'}, 'secondaryIdInfos': [{'id': 'INSTEAD 5 years outcomes', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Rostock'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stentgraft', 'description': 'Stentgraft', 'interventionNames': ['Device: endoprosthesis']}, {'type': 'NO_INTERVENTION', 'label': 'Medical management', 'description': 'Antihypertensive medication', 'interventionNames': ['Device: endoprosthesis']}], 'interventions': [{'name': 'endoprosthesis', 'type': 'DEVICE', 'otherNames': ['Talent endoprosthesis'], 'description': 'Thoracic aortic stentgraft', 'armGroupLabels': ['Medical management', 'stentgraft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18057', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'University Hospital Rostock; Heart Center', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Christoph A Nienaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rostock'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rostock', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christoph A.Nienaber, MD', 'oldOrganization': 'University of Rostock, Medical School; Dept. of Medicine/Cardiology'}}}}