A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection (ADSORB)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation [ Time Frame: 1 year ] [ Designated as safety issue: No ]Subjects with either partial/no false lumen thrombosis, aortic rupture, aortic dilatation, or lack of 1 year imaging met this composite outcome.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Device: Gore TAG Endoprosthesis
Implant Gore TAG device with Best Medical therapy per physician discretion
Other Name: Gore TAG Endoprosthesis
Active Comparator: 2
Other: Best Medical Therapy
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.
Other Name: Best Medical Therapy
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.