Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Dissection

Intervention / Treatment
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* Device: endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No contraindication the general anesthesia and ventilation Type B aortic dissection that occurred 2-52 weeks prior to randomization Diameter of the targeted aortic segment < 6 cm Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form Availability for appropriate follow-up visits during the F/U period of 5 years Capability to follow all study requirements Exclusion Criteria: Pregnancy Thrombocytopenia Ongoing anticoagulation therapy Renal failure and/or creatinine > 2,4 mg% Complete thrombosis of false lumen Cancer likely to cause death within 1 year Enrollment in another clinical study Unwillingness to cooperate with study procedures or F/U visits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stentgraft<br>Stentgraft | Device: endoprosthesis<br>* Thoracic aortic stentgraft<br>* Other names: Talent endoprosthesis;|
| No Intervention: Medical management<br>Antihypertensive medication | Device: endoprosthesis<br>* Thoracic aortic stentgraft<br>* Other names: Talent endoprosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 5 years post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aorta-specific mortality |  | 5 years post randomization | 
| Progression of disease |  | 5 years | 
| Aortic remodeling |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dissection, Aorta, Surgery