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This was a prospective, multicenter, randomized trial conducted at 12 hospitals throughout China. Enrolled adults with unruptured large/giant intracranial aneurysms were randomly assigned (1:1) to receive either Enterprise stent-assisted coiling or Tubridge flow diverter implantation. The primary end point was complete occlusion at 6-month follow-up, while secondary end points included technical success, mortality, target vessel–related stroke, aneurysm bleeding, in-stent stenosis, parent artery occlusion, and the frequency of all adverse events. The results of 6-month follow-up imaging included complete occlusion rates of 75.34% versus 24.53% for the Tubridge and stent-assisted coiling groups, respectively. This trial showed a higher rate of large and giant aneurysm obliteration with the Tubridgeflow diverter over Enterprise stent-assisted coiling. However, this higher obliteration rate came at the cost of a nonsignificantly higher rate of complications.

Consecutive patients with intracranial aneurysms treated with the FRED between February 2012 and March 2015 were retrospectively reviewed. Complications and adverse events, transient and permanent morbidity, mortality, and occlusion rates were evaluated. A total of 579 aneurysms in 531 patients were treated with the FRED. Seven percent of patients were treated in the acute phase of aneurysm rupture. The median aneurysm size was 7.6 mm and the median neck size 4.5 mm. There was progressive occlusion witnessed with time, with complete occlusion in 18 (20%) aneurysms followed for up to 90 days, 141 (82.5%) for 180 days, 116 (91.3%) for 1 year, and 122 (95.3%) aneurysms followed for more than 1 year. This retrospective study in real-world patients demonstrated the safety and efficacy of the FRED for the treatment of intracranial aneurysms.