Clinical Trial: INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Medtronic Bakken Research Center

Current Primary Outcome: all-cause mortality [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: 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: 2 years ]

Information By: Medtronic Cardiovascular

Dates:
Date Received: September 4, 2007
Date Started: February 2002
Date Completion:
Last Updated: October 28, 2015
Last Verified: September 2007