Thank you. Next we'll hear from Dr. Griesenaar about the European Multi-Center Study for Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Necked Intracranial Aneurysms, the EUROFRET study. Good afternoon. I have no relevant disclosures. This study was recently published in AJNR. The FRET is a dual-layer flow-diverting stent that consists of an inner layer that has the flow-diverting characteristics and an outer layer that exerts their stability and radial force. It currently has the CE mark, but is not currently available in the United States. There is a trial ongoing in the U.S. on FRET that has finished enrollment, but the results have not been reported yet. This study was a registry-designed study across 15 centers across Europe, enrolling patients between 2012 and 2015. It was, as I said, a registry approach, so there were no stringent inclusion or exclusion criteria, but the centers were encouraged to enroll consecutive patients. A total of 579 aneurysms were treated in 531 patients. On average, those patients were 54 years old. About 12 percent of aneurysms had presented with a rupture. Multiple aneurysms were treated in 26 percent of patients. The median diameter was 7.6 millimeters, and the vast majority of these aneurysms were located in the ophthalmic segment of the internal carotid artery, but it included all locations, including 6 percent in the posterior circulation. When it comes to angiographic outcome, at three months, 20 percent of aneurysms occluded. This rate dramatically increased and reached 95 percent at aneurysms that were treated or were observed after one year. Incomplete occlusion was associated with large and giant aneurysms greater than 2 centimeters in maximum diameter. Morbidity and mortality was as follows. Transient neurologic morbidity that resolved within 90 days was encountered in 3.2 percent of patients. Permanent morbidity was encountered in 0.8 percent of patients, and mortality was 1.5 percent. Results of M&M were larger aneurysm size as well as location of the aneurysm in the posterior circulation. In conclusion, this is the largest study on FRED to date. It shows a very favorable occlusion profile with acceptable morbidity and mortality. The fact that multiple institutions contributed to the study assures generalizability of the findings. There are several limitations, including selection bias on the level of the treating interventionalist as well as the treating center. Even though centers were encouraged to perform platelet function testing, there were some variations in the type of tests that was performed, as well as variations in the anti-platelet regimen used adjunctive coiling and imaging follow-up. Even though these patients were enrolled prospectively, part of the data collection was performed retrospectively, and angiographic outcome was assessed by an independent radiologist at the enrolling institution, but it was not done at a central core laboratory. Thank you.

European Multi-Center Study

Evaluation

Dual-Layer Flow-Diverting Stent

Wide-Necked Intracranial Aneurysms

EUROFRET