Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
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:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Study Overview
Official Title:
INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSTEAD
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 Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: