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

Study Overview
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Brief Summary
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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
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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.

Official Title
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INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Conditions
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Aortic Diseases

Intervention / Treatment
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* Device: Medtronic Talent Stent-Graft-System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No contraindication for an anesthetic procedure with intubation Type B aortic dissection that occurred 2-52 weeks before randomization Diameter of the targeted aortic segment ≤6 cm Aortic kinking <75° The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form Availability for the appropriate follow-up visits during the follow-up period Capability to follow all study requirements Exclusion Criteria: Pregnant woman Thrombocytopenia or ongoing anticoagulation therapy Renal failure and/or creatinine >2.4 mg% Complete thrombosis of the false lumen Ongoing infection Cancer is likely to cause death within 1 year Enrolment in another clinical study Unwillingness to cooperate with study procedures or follow-up visits
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: 1<br>Anti-hypertensive medical treatment | Device: Medtronic Talent Stent-Graft-System<br> <br> * Other names: Endograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy. |  | 5 years | 

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