A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection

Study Overview
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Brief Summary
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The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.

Detailed Description
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Dissection of the aorta is a medical emergency requiring immediate surgery. Type B dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. However, the treatment of patients with uncomplicated, acute type B dissections is controversial. Best medical therapy (BMT) is the standard of care in these cases since surgical repair offers no additional survival advantage. However, Endoluminal stent graft therapy with the GORE TAG Thoracic Endoprosthesis (GORE TAG device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type B dissection. The goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.

Official Title
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A Randomized European Study Comparing Endoluminal Stent Grafting and Best Medical Therapy (BMT) to BMT Alone in the Treatment of Acute Uncomplicated Type B Aortic Dissection

Conditions
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Aortic Diseases

Intervention / Treatment
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* Device: Gore TAG Endoprosthesis
* Other: Best Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of acute uncomplicated type B aortic dissection Able to tolerate endotracheal intubation and general anesthesia Maximum transverse diameter of the descending thoracic aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology. Arterial anatomy is appropriate for stent graft therapy Exclusion Criteria: ASA classification = V Severe renal insufficiency defined as SVS risk renal status = 3 Severe respiratory insufficiency defined as SVS risk pulmonary status = 3 Presence of connective tissue disease Active infection or active vasculitides Positive pregnancy test Participation in another medical research study within 3 months of study enrollment Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass), or major surgery within 30 days of study enrollment History of drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: 1<br>TAG+BMT | Device: Gore TAG Endoprosthesis<br>* Implant Gore TAG device with Best Medical therapy per physician discretion<br>|
| Active Comparator: 2<br>BMT alone | Other: Best Medical Therapy<br>* Best Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation | Subjects with any of the following met this composite outcome: partial/no false lumen thrombosis aortic rupture aortic dilatation lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image) | 1 year |