Gore TAG Branch Device Being Studied in Proximal Descending Thoracic Aortic Aneurysms

November 5, 2014—VIVA Physicians, Inc. announced that Michael Dake, MD, presented the trial plan and reported preliminary findings from the Gore TAG Thoracic Branch Zone 2 Feasibility Study during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.

According to the VIVA announcement, this nonrandomized, multicenter, prospective feasibility study was conducted at up to six clinical investigative sites in the United States. The primary objective of the study is to assess the feasibility of the Gore TAG thoracic branch endoprosthesis (TBE, Gore & Associates) to treat aneurysms involving the proximal descending thoracic aorta. The Gore TAG TBE has an aortic component, a side branch component, and an optional aortic extender. An additional investigational accessory, the Gore DrySeal side branch introducer sheath, is used in conjunction with the TBE.

The study will enroll a minimum of 20 and up to a total of 40 patients with aneurysms involving the proximal descending thoracic aorta that require treatment. Patients may be enrolled into the clinical study provided all inclusion and no exclusion criteria are met. Enrolled patients will be followed after the initial treatment for 5 years or until termination of the trial. The patients will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months after treatment.

The primary endpoints of the study will be successful access and deployment of the branched TAG device and procedural side branch patency assessed by angiography at the conclusion of the endovascular procedure. The secondary endpoints include 1-month side branch primary patency and 1-month device-related endoleaks, both assessed by an independent core lab. The primary endpoints provide a measurement of the feasibility of implantation of the Gore TAG TBE.

Dr. Dake advised that preliminary site-reported data from the first nine patients reveal 100% access and deployment success and that among those patients with follow-up, there are no deaths, no neurological events, and 100% side branch component patency.