The first patient has been enrolled into the HERCULES trial, which compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) in the treatment of abdominal aortic aneurysms (AAAs) with wide proximal necks.
HERCULES is an investigator-driven trial led by Michel Reijnen, MD, a consultant vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands, and Konstantinos Donas, MD, head of the Department of Vascular and Endovascular Surgery at Asklepios Clinic Langen in Langen, Germany, in collaboration with Medtronic. Rijnstate Hospital is sponsoring the trial.
Patients will be randomly allocated 1:1 into ESAR and EVAR groups: the former arm will be treated with the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System, and the latter using the Endurant II/IIs stent graft system.
A total of 300 participants will be recruited worldwide at approximately 20 hospitals in Europe and another 20 in the U.S. They will be followed out to five years.
The primary endpoint of the trial will be the absence of type Ia endoleak, migration of the upper portion of the stent graft of ≥5mm (as compared to the one-month post-treatment CT scan), and aneurysm sac growth of ≥5mm (as compared to the one-month post-treatment CT scan).
