The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology—First Multicenter Experience in 161 Patients

BACKGROUND AND PURPOSE: Flow diverters with antithrombotic coatings are increasingly used to improve the safety of flow diverter treatments of intracranial aneurysms.

This study aimed to investigate the safety and short-term efficacy of the new FRED X flow diverter.

MATERIALS AND METHODS: Medical charts and procedural and imaging data of a consecutive series of patients with intracranial aneurysms who were treated with the FRED X at 9 international neurovascular centers were retrospectively analyzed.

RESULTS: One hundred sixty-one patients (77.6% women; mean age, 55 years) with 184 aneurysms (11.2% acutely ruptured) were included in this study.

Most aneurysms were located in the anterior circulation (77.0%), most frequently at the ICA (72.7%).

The FRED X was successfully implanted in all procedures.

Additional coiling was performed in 29.8%.

In-stent balloon angioplasty was necessary in 2.5%.

The rate of major adverse events was 3.1%.

Thrombotic events occurred in 7 patients (4.3%) with 4 intra- and 4 postprocedural in-stent thromboses, respectively (1 patient had both peri- and postprocedural thrombosis).

Of these thrombotic events, only 2 (1.2%) led to major adverse events (ischemic strokes).

Postinterventional neurologic morbidity and mortality were observed in 1.9% and 1.2%, respectively.

The rate of complete aneurysm occlusion after a mean follow-up of 7.0 months was 66.0%.

CONCLUSIONS: The new FRED X is a safe and feasible device for aneurysm treatment.

In this retrospective multicenter study, the rate of thrombotic complications was low, and the short-term occlusion rates are satisfactory.