August 24, 2023—The Foundation for Cardiovascular Research and Education (FCRE) announced that the first United States procedure has been completed in the SOCRATES randomized controlled trial, which compares endosuture aneurysm repair (ESAR) and fenestrated endovascular aneurysm repair (FEVAR) in patients with hostile infrarenal neck abdominal aortic aneurysms (AAAs).
FCRE announced that the first patient in the SOCRATES study in the United States was treated by Co-Principal Investigator Brant W. Ullery, MD.
He commented, “We are grateful for the opportunity to jump-start United States enrollment efforts and join our European colleagues on this important global effort to better clarify optimal endovascular treatment paradigms for patients with complex aortic neck anatomy.”
Dr. Ullery is with Providence Heart & Vascular Institute in Portland, Oregon. Professor Giovanni Torsello, MD, is also Co-Principal Investigator.
According to the press release, the randomized, postmarket, head-to-head SOCRATES study was designed to determine whether clinical outcomes of ESAR and FEVAR are equivalent in the treatment of infrarenal AAAs with a core lab–measured short proximal neck length of 4 to 15 mm and minimal infrarenal sealing zone of 8 mm.
The study, which is organized globally by FCRE in collaboration with Medtronic as funding partner, randomizes patients 1:1 to either ESAR with the Endurant II/IIs stent graft system (Medtronic) and Heli-FX EndoAnchor system (Medtronic) or FEVAR with the Zenith Fenestrated AAA endovascular graft (Cook Medical) and Anaconda fenestrated stent graft (Terumo Interventional Systems).
SOCRATES will enroll approximately 200 patients at up to 40 sites globally, noted FCRE. The prespecified safety endpoint is freedom from major adverse events (all-cause mortality, bowel ischemia, myocardial infarction, respiratory failure, disabling stroke, access-related complications, procedural blood loss, permanent paraplegia or paraparesis, renal complications) through 30 days. The composite effectiveness endpoint is technical success at index procedure, freedom from type IA or type III endoleaks, freedom from aneurysm-related mortality, and freedom from secondary reinterventions through 12 months.
FCRE noted in its press release that results will provide evidence to more selectively tailor treatment of AAA with short infrarenal neck lengths.
Heli-FX has FDA clearance for distribution in the United States and CE Mark approval for distribution in Europe. Zenith Fenestrated is available in the United States and Europe, and Anaconda is available outside the United States.