- The study involves up to 45 sites in the US.
- Approximately 210 patients will be enrolled.
- Patients will be followed for 5 years post-procedure.
- Getinge's iCast® stent is used as a bridging stent.
Study Overview
Terumo Aortic has initiated the Fenestrated TREO® pivotal IDE study in the US, enrolling the first patient to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms. The study uses the Fenestrated TREO® Abdominal Stent-Graft System, with Getinge’s iCast® covered stent system as a bridging stent.
Study Details
The study will be conducted across up to 45 leading healthcare institutions in the US, with an anticipated enrollment of approximately 210 patients. These patients will be divided into three study arms: juxtarenal aneurysms, suprarenal aneurysms, and those with chronic kidney disease. Participants will be monitored for five years following the procedure.
Key Personnel
The first patient was enrolled by Dr. J. Westley Ohman, Director of Vascular Surgery at Washington University School of Medicine. The National Principal Investigator is Dr. Benjamin Starnes, a professor at Harborview Medical Center.
