NCT01415804

Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Rostock · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.

Detailed description

Patients \> 18 years with type B aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only stable patients without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. Long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	endoprosthesis	Thoracic aortic stentgraft

Timeline

• Start date: 2002-02-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2011-08-12
• Last updated: 2011-08-12

Locations

1 site across 1 country: Germany