Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
NCT ID: NCT01415804
Last Updated: 2011-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
140 participants
INTERVENTIONAL
2002-02-28
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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stentgraft
Stentgraft
endoprosthesis
Thoracic aortic stentgraft
Medical management
Antihypertensive medication
endoprosthesis
Thoracic aortic stentgraft
Interventions
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endoprosthesis
Thoracic aortic stentgraft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type B aortic dissection that occurred 2-52 weeks prior to randomization
* Diameter of the targeted aortic segment \< 6 cm
* Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form
* Availability for appropriate follow-up visits during the F/U period of 5 years
* Capability to follow all study requirements
Exclusion Criteria
* Thrombocytopenia
* Ongoing anticoagulation therapy
* Renal failure and/or creatinine \> 2,4 mg%
* Complete thrombosis of false lumen
* Cancer likely to cause death within 1 year
* Enrollment in another clinical study
* Unwillingness to cooperate with study procedures or F/U visits
18 Years
90 Years
ALL
No
Sponsors
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University of Rostock
OTHER
Responsible Party
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University of Rostock, Medical School; Dept. of Medicine/Cardiology
Principal Investigators
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Christoph A Nienaber, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rostock
Locations
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University Hospital Rostock; Heart Center
Rostock, Mecklenburg-Vorpommern, Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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INSTEAD 5 years outcomes
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCT00525356
Identifier Type: -
Identifier Source: org_study_id
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