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Investigation of Stent-grafts in Aortic Dissection (INSTEAD) — INSTEAD  

Aortic Dissection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01415804
Study type Interventional
Source University of Rostock
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 2002
Completion date March 2011
View Details
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