INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection|
- all-cause mortality [ Time Frame: 1 year ]
- 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. [ Time Frame: 5 years ]
|Study Start Date:||February 2002|
|Study Completion Date:||September 2007|
Active Comparator: 1
Anti-hypertensive medical treatment
Device: Medtronic Talent Stent-Graft-System
Other Name: Endograft
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."
Only 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.
Primary 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.
|Medtronic Bakken Research Center|
|Maastricht, Netherlands, 6229 GW|
|Principal Investigator:||C A Nienaber, MD, FESC, FACC||Division of Cardiology and Internal Medicine Department, Rostock University, Germany.|