NCT00525356

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

INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Diseases

Interventions

Type	Name	Description
DEVICE	Medtronic Talent Stent-Graft-System

Timeline

• Start date: 2002-02-01
• Completion: 2007-09-01
• First posted: 2007-09-05
• Last updated: 2015-10-29

Locations

1 site across 1 country: Netherlands