GORE® Ascending Stent Graft for Aortic Dissection

(ARISE III Trial)

This trial tests the GORE® Ascending Stent Graft (ASG) to evaluate its safety and effectiveness in treating Type A aortic dissections, a serious condition where the inner layer of the aorta tears. The trial includes two groups: the primary group focuses on recent cases, while the secondary group includes those with the condition for up to 90 days. Suitable candidates have recently experienced a Type A aortic dissection, have an aorta compatible with the device, and are considered high-risk for traditional surgery. As an unphased trial, this study allows patients to contribute to groundbreaking research and potentially benefit from an innovative treatment option.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

A previous study tested the GORE Ascending Stent Graft on patients with acute type A aortic dissection. The results showed that patients handled the stent graft well, with no major safety issues. Another study found the device effective for treating aortic disease, indicating its safety for similar conditions. These studies offer reassurance about the GORE Ascending Stent Graft's safety in treating aortic problems.¹²³⁴⁵

The GORE® Ascending Stent Graft is unique because it offers a minimally invasive approach to treating aortic dissections, which traditionally require open-heart surgery. This stent graft is designed to be placed in the ascending aorta, providing a less invasive option with potentially quicker recovery times and fewer complications than standard surgical procedures. Researchers are excited about this treatment because it could expand options for patients who might not be eligible for surgery, offering a new avenue of hope for those suffering from this serious condition.

Research shows that the GORE® Ascending Stent Graft (ASG) could be a promising option for treating aortic dissections, which are serious tears in the main artery of the body. This trial will evaluate the ASG in two separate arms. The primary arm will assess the ASG's safety and effectiveness in patients with dissection chronicity of 30 days or less. The secondary arm will involve patients not eligible for the primary arm, with dissection chronicity up to 90 days. Studies on similar Gore devices have shown good long-term results, with effective treatment outcomes even five years after the procedure. The ASG is designed to fit precisely in the upper part of the aorta, which is important for successful treatment. Early findings suggest that this design might be safer and more effective than other treatments. Overall, there is confidence in the ASG's potential to effectively manage aortic dissections.⁴⁶⁷⁸⁹