Aortic Science Made Simple: Diving into the ARISE III trials ~ Aditi Darodkar

Aortic Science Made Simple, Issue 2

Title: Diving into the ARISE III trials 

On Dec 11, 2025, W. L. Gore & Associates announced the implantation of the GORE Ascending Stent Graft (ASG) as part of the ARISE III trial. With over 22 locations including Emory Healthcare in Georgia and Stanford Medicine in California, ARISE III is investigating the ASG as a minimally invasive option for acute type A aortic dissection patients who are considered too high-risk for open-heart surgery. 

	ARISE I	ARISE II	ARISE III
Purpose	Initial assessment over device safety and deployment	Aortic aneurysms and chronic dissections	Acute Type A aortic dissections
Patient Population	19	370	112
Timeline	Completed	Ongoing- estimated to be completed by 2029	Ongoing- estimated to be completed by 2030

“The current gold standard to treat type A dissections is open surgery by making a sternotomy [a cut straight down the breastbone to open the chest], placing the patient on cardiopulmonary bypass [a heart lung machine that temporarily functions for the heart and lung during open surgery], and replacing the dissected ascending aorta [with] a surgical graft,” explained Dr. Bradley Leshnower, the Director of thoracic aortic surgery at Emory Healthcare and the surgeon who performed the first ASG implantation. 

However, the risks for open surgery– especially in patients of advanced age– are immense, ranging from stroke, infections and kidney damage to prolonged recovery and sometimes death (Cleveland Clinic). “ What an endovascular approach offers is [that] everything is done through a needle puncture in the groin. Rather than [replacing] the aorta, you line the inner [wall of the aorta] with a stent that enforces it,” said Dr. Claire Watkins, a cardiothoracic surgeon and clinical assistant professor at Stanford Medicine. “People spend far fewer days in the hospital [and] they are mostly recovered by the time they go home.” According to Leshnower, this approach may also improve surgical morbidity and postoperative quality of life. 

While endovascular stent grafts have been available for type B dissections for years, their use in type A dissections has been rare. The reason largely stems in the location: type A dissection is a tear in the inner wall of the ascending aorta, while type B refers to a descending aorta dissection. The curvature of the ascending aorta makes it particularly difficult to place a stent graft. The ASG overcomes this hurdle by being very flexible, Watkins said. “It’s very accurately placed in the ascending aorta [because the surgeon is] able to adjust the angle at which the stent, partially deploy [release] it, make microadjustments to its position and then fully deploy it.” Successful ASG placement and subsequent patient outcomes are evaluated by angiograms, a test that uses contrast dye to image blood vessels.

Despite the benefits, the financial aspect for patients is relatively unknown. Even though the postsurgical hospital stay decreases, the cost of the stent itself is higher. Furthermore, the U.S. Food and Drug Administration (FDA) has approved the ASG solely for use in the ARISE III trial. “What that means is that if I want to use it, I can't just go to the shelf and grab it,” said Leshnower. “The patient has to be enrolled in [the] clinical trial,” or qualify for compassionate use, a process by which patients in life-threatening conditions who do not meet all the criteria receive unapproved medical products outside of clinical trials. 

The current criteria for the ARISE III trial patients includes “[age] over eighty, prior cardiac surgery, [and] different organ system dysfunction [such as] severe kidney or lung disease, [making the patient] high risk for open surgery,” said Watkins. There is also “strict anatomic criteria,” added Leshnower. “The tear in the aorta must be located roughly two centimeters above the aortic root so that the stent graft has enough room to seal off the tear, [and] the aorta cannot be too large.”

The success of this trial could allow an “alternative solution to patients who at this point are elderly and too frail or sick to undergo open heart surgery,” Leshnower said. According to Watkins, the ASG may never replace open surgery, but instead provides access to a treatment that currently doesn’t exist to prolong life.