First U.S. Patient Enrolled in SOCRATES Trial Comparing ESAR and FEVAR for Short-Neck AAA

The first surgery performed in the United States was conducted by the Director of Vascular and Endovascular Medicine at the Providence Heart and Vascular Institute in Portland, USA.Brant UlleryProceed, he isCo-Principal Investigator of the SOCRATES Trial。

The sponsor of the trial, the Foundation for Cardiovascular Research and Education (FCRE), said: "This randomized, post-market, head-to-head study aims to determine whether the clinical outcomes of ESAR and FEVAR are equivalent in treating infrarenal AAA with a proximal neck length of 4-15 mm and a minimum infrarenal seal zone of 8 mm, as measured by the core laboratory.”

The studyByFCRE collaborates with Medtronic to organize globally,In1:1 ratioRandom AllocationPatients, respectively usingEndurant Ⅱ/Ⅱs Stent Graft System (Medtronic) and Heli-FX EndoAnchor System (Medtronic)ProceedESAR, orUseZenith Fenestration（Cook Medical) orAnaconda Fenestration（Terumo Medical）ProceedFEVAR。

Heli-FX has been approved by the U.S. Food and Drug Administration (FDA)Approved for distribution in the United States,And has obtained distribution in EuropeCE Mark Approved. Zenith Fenestrated is available in the United States and Europe.AndAnaconda is available for sale outside the United States.

SOCRATESPlan to expand to up to40 LocationsRecruit Approximately204 patients. The pre-specified safety endpoint isWithin 30 daysNo MajorAdverse EventOccurrence。ComprehensiveThe endpoint of effectiveness is the technical success of the index operation, withoutType ⅠA or Type Ⅲ endoleak, no aneurysm-related mortality, and no secondary reintervention within 12 months.

At this year's Leipzig Interventional Course (LINC 2023; JuneDay 6~On the 9th, in Leipzig, Germany，When talking about the design of SOCRATES, from Münster, GermanyCity'sSt. Francis HospitalUllery's Co-Chief InvestigatorGiovanni TorselloFurther elaborated on the intent of the trial, he saidThis is the "first comparison" study comparing ESAR and FEVAR.

First, regarding contemporary data on FEVAR and its efficacy, Torsello cited a paper by Magnús Sveinsson (Helsingborgs lasarett, Helsingborg, Sweden) et al., which reported a primary target vessel patency rate of 90% after three years; however, in this study, the aneurysm-related mortality rate was 5.3%, and 39.4% of patients required reintervention after undergoing FEVAR.

On the other hand, the ANCHOR registry is a trial evaluating the persistence of treatment with the Heli-FX EndoAnchor System (Medtronic). The five-year results show a 90.1% rate of freedom from aneurysm-related mortality, a 95.6% rate of freedom from aneurysm rupture, and a 76.9% rate of freedom from secondary interventions.

These retrospective analyses of ESAR and FEVAR patients indicate that their early outcomes are similar, and importantly, a head-to-head comparison of these two types of procedures is warranted.

Torsello told LINC attendees that poor aortic aneurysm necks can lead to "loss of proximal seal over time," noting that short aneurysm necks are associated with an increased risk of Type IA endoleaks and secondary interventions, ultimately asking:How Should We Treat Patients with Short-necked Tumors?"And this is where SOCRATES comes in.

Torsello said, "If we could establish the first comparative trial treating this type of patient, and if we could learn more about the fate of those treated in these ways, it would be a wonderful trial."

In addition, he added that the expansion of trial registration from the initial Europe to the United States would make a significant contribution to this prospective study.

Endurant Ⅱ/ⅡsIt is a stent graft applicable for the treatment of infrarenal or juxtarenal abdominal aortic aneurysms or aortoiliac aneurysms. It has been approved for marketing by regulatory authorities such as the FDA, CE, and NMPA. The Endurant series products are designed for abdominal aortic aneurysms (AAA).）Provides Standard Care for Treatment，Has a tradition of clinical success.OnlyThe Endurant series of products are designed to addressTumor Cyst RetractionIssues, with profound clinical experience, favorable outcomes, and the most effective data for any single graft in daily or special challenges. In the past five years, everyOne in three EVAR cases used Endurant. Ⅱ/Ⅱs, covering more than450,Used in 000 patients.

Heli-FX EndoAnchorThe system is designed to fix and seal endovascular aortic grafts and natural arteries. The system is suitable for cases where endovascular grafts appear.DisplacementOr endoleak, as well as patients at risk of such complications, can achieve sealing and enhanced radial fixation between the aortic graft and the native artery.

ZenithFenestrated AAA Endovascular Graft Modular SystemConsists of three parts：Proximal graft, distal bifurcated graft, and one iliac leg. The graft modules are made of...LayerWoven polyester fabric sewn onto self-expanding stainless steelCook-Z StentUp,WeavingPolyesterAnd monofilament polypropylene sutures. These modulesByFull StentChemical, to provide stabilityGenderAndExpansion Force. In addition,Cook-Z stent provides the necessary connection and seal between the graft and the vessel wall.Auxiliary Device, such as body extension, leg extension, converter,Iliac OcclusionIt may alsoNeed. EveryA deviceEach has its own independent delivery system. Each component has a certain length and diameter, allowing doctors to customize according to the patient's anatomy.Device。

Anaconda FenestrationCan precisely repair unique aortic aneurysms, canFlexible DesignInstituteRequiredDevice, to meet the needs of patients and treatment plans. Eight were designedIndividualActive fixation anchor enables the system to have effective positioning and migration.Resistance, while achieving the overall relocation function of the system, Optimize Anchoring。ExceedWith experience in 29,000 cases, a technical success rate of 99.4%, a 96.8% rate of no limb thrombosis, 76.2% aneurysm sac regression, a stability rate of 19%, and a 99.1% freedom from aneurysm-related mortality.

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