SOCRATES Study Begins in Germany to Compare ESAR and FEVAR Treatments of AAA

June 15, 2021—St. Franziskus-Hospital in Münster, Germany, announced the commencement of the postmarket SOCRATES study comparing endosuture aneurysm repair (ESAR) to fenestrated endovascular aneurysm repair (FEVAR) in patients with hostile infrarenal neck abdominal aortic aneurysms (AAAs).

Michel Bosiers, MD, and Martin Austermann, MD, at St. Franziskus-Hospital in Münster, Germany, treated the first patient in the SOCRATES study, which is led by Principal Investigator Professor Giovanni Torsello, MD.

“The first patient with an 8-mm infrarenal neck was successfully treated in the SOCRATES study,” commented Dr. Bosiers in the hospital’s announcement. “I am looking forward to the results of this exciting trial.”

According to St. Franziskus-Hospital, the SOCRATES study is a randomized controlled trial designed to demonstrate that ESAR clinical outcomes are equivalent to FEVAR clinical outcomes in the treatment of infrarenal AAAs with short proximal neck lengths between 4 and 15 mm (core-lab measured) and a minimum infrarenal sealing zone of 8 mm. Patients in the study will be randomized 1:1 for either ESAR or FEVAR.

The SOCRATES study will enroll approximately 200 patients at up to 40 sites globally and includes a prespecified safety endpoint of freedom from major adverse events through 30 days. Major adverse events include all-cause mortality, bowel ischemia, myocardial infarction, respiratory failure, disabling stroke, access-related complications, procedural blood loss, permanent paraplegia or paraparesis, and renal complications.

The composite effectiveness endpoint includes technical success at index procedure and freedom from (1) type IA or III endoleaks, (2) aneurysm-related mortality, and (3) secondary reinterventions through 12 months.

St. Franziskus-Hospital advised that the results from the head-to-head study will provide evidence to more selectively tailor treatment of AAA with short infrarenal neck lengths.

The hospital’s announcement noted that ESAR uses a standard EVAR graft providing augmented transmural radial fixation and/or sealing to the proximal end of the endograft, below the renal arteries with no renal cannulation. FEVAR uses a custom-made endograft that extends above the renal arteries, cannulating the visceral vessels and placing endografts within these vessels.

Devices used in the ESAR arm include the Endurant II/IIs stent graft system (Medtronic) and the Heli-FX EndoAnchor system (Medtronic). Devices used in the FEVAR arm include the Zenith fenestrated AAA endovascular graft (Cook Medical) and the Anaconda fenestrated stent graft (Terumo Aortic).

The Heli-FX system is cleared by the FDA for commercialization in the United States and has been granted CE Mark approval for sale in Europe. The Zenith fenestrated AAA endovascular stent graft is available in the United States and Europe. The Anaconda device is available outside the United States, stated St. Franziskus-Hospital.