Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-08 @ 11:24 PM
Study NCT ID:
NCT00525356
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2007-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001018', 'term': 'Aortic Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aorta', 'Dissection', 'Thoracic'], 'conditions': ['Aortic Diseases']}, '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': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare treatment with an endograft prothesis versus antihypertensive treatment in patients with a dissection of the thoracic aorta.', 'detailedDescription': 'Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."\n\nOnly patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.\n\nPrimary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (\\>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No contraindication for an anesthetic procedure with intubation\n* Type B aortic dissection that occurred 2-52 weeks before randomization\n* Diameter of the targeted aortic segment ≤6 cm\n* Aortic kinking \\<75°\n* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form\n* Availability for the appropriate follow-up visits during the follow-up period\n* Capability to follow all study requirements\n\nExclusion Criteria:\n\n* Pregnant woman\n* Thrombocytopenia or ongoing anticoagulation therapy\n* Renal failure and/or creatinine \\>2.4 mg%\n* Complete thrombosis of the false lumen\n* Ongoing infection\n* Cancer is likely to cause death within 1 year\n* Enrolment in another clinical study\n* Unwillingness to cooperate with study procedures or follow-up visits'}, 'identificationModule': {'nctId': 'NCT00525356', 'acronym': 'INSTEAD', 'briefTitle': 'INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection', 'orgStudyIdInfo': {'id': 'INSTEAD trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Anti-hypertensive medical treatment', 'interventionNames': ['Device: Medtronic Talent Stent-Graft-System']}], 'interventions': [{'name': 'Medtronic Talent Stent-Graft-System', 'type': 'DEVICE', 'otherNames': ['Endograft'], 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 GW', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Medtronic Bakken Research Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'C A Nienaber, MD, FESC, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology and Internal Medicine Department, Rostock University, Germany.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}}}}