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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: W.L.Gore & Associates

Current Primary Outcome: Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation [ Time Frame: 1 year ]

Original Primary Outcome: Composite of false lumen thrombosis, aortic rupture, and aortic dilatation [ Time Frame: 1 year ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: August 25, 2008
Date Started: August 2008
Date Completion:
Last Updated: November 8, 2013
Last Verified: November 2013