Two-Year Data Support Conformable Gore TAG Thoracic Endograft

February 26, 2015—William D. Jordan Jr, MD, et al published results of a prospective multicenter trial of the Conformable Gore TAG (CTAG) thoracic endograft (Gore & Associates) in the Journal of Vascular Surgery (2015;61:589–595).

According to the investigators, the CTAG was specifically designed to be more conformable in tortuous anatomy, more resistant to compression, and more accommodating to various aortic diameters compared with the original Gore TAG device.

The investigators concluded that this next-generation thoracic endograft has a low rate of major device events through 2 years, with no graft compressions or device failures. The data for this new endograft demonstrate favorable outcomes and confirm low risks for treatment for patients with thoracic aortic aneurysms. The investigators advised that follow-up will be continued for 5 years.

As summarized in the Journal of Vascular Surgery, this prospective, multicenter regulatory study evaluated the safety and effectiveness of the CTAG endograft in the repair of descending thoracic aortic aneurysms. The study’s primary endpoint was freedom from major device event through 1 month after treatment. Two-year outcomes included aneurysm-related morbidity (endoleaks and morphology changes), aneurysm-related mortality, and all-cause mortality.

The study enrolled 51 patients between October 2009 and October 2010, with at least one endograft implanted in 50 patients. After the regulatory study successfully completed its primary endpoint and expanded to a continued-access phase, 15 additional patients were enrolled in the continued-access arm of the study from February 2011 until September 2011 for a total treatment group of 66 patients for the early results and 65 patients for the long-term clinical results with imaging evaluation, noted the investigators in the Journal of Vascular Surgery.