Purpose The ULTRA Registry is an ongoing multicenter, national, prospective study designed to assess aneurysm occlusion rates and safety profile of the Target® Ultra coil and the Target® Nano coil (Stryker Neurovascular, Freemont, CA, USA) in the treatment of small intracranial aneurysms.
Materials and methods The ULTRA registry is a prospective database of patients with small (<5 mm) intracranial aneurysms treated with Target® Ultra and Target® Nano coils. The primary endpoint is target aneurysm re-intervention or target aneurysm rupture during the follow up period, and secondary endpoints include residual aneurysm and device related or procedural adverse events.
Results Patients were enrolled from December 2013 to January 2019. A total of 100 patients with 100 aneurysms were included, including 49 ruptured aneurysms. The mean age was 56±11.6 years, and 75% were female. Mean aneurysm volume was 17.7±12.4 mm3 with mean maximum and minimum aneurysm diameters of 3.7±0.9 mm and 2.6±0.7 mm, respectively. Mean packing density was 33.9%±16.6%. Stent and balloon assistance was used in 21 and 19 cases, respectively. No flow diverters were used. Initial complete occlusion, minimal residual, and residual aneurysm were reported in 45, 52, and 3 cases, respectively. There were no coil related adverse events and no intraoperative aneurysm ruptures. There were 6 procedural related adverse events: 3 ischemic strokes, 1 cerebral hemorrhage from wire perforation, 1 groin hematoma, and 1 groin infection. There was one procedural related death in the patient with cerebral hemorrhage complication. First follow up using MR angiography at a mean of 5.8±2.3 months demonstrated complete occlusion, minimal residual, and residual aneurysm in 64% (42/66), 27% (18/66), and 9% (6/66) of cases. Second follow up using digital subtraction angiography at a mean of 15.8±5.4 months demonstrated complete occlusion, minimal residual and residual aneurysm in 62% (26/42), 26% (11/42), and 12% (5/42) of cases. To date, there have been 6 aneurysm retreatments (9%; 6/66).
Conclusion Initial results of the ULTRA Registry demonstrate adequate efficacy and safety profiles.
Disclosures G. Jindal: 1; C; Stryker Neurovascular, Microvention. 2; C; Penumbra. R. Almardawi: None. R. Gupta: 1; C; Stryker Neurovascular, Rapid Medical. 2; C; Stryker Neurovascular, Ceronovous, Rapid Medical. 6; C; CEC committee MIND trial, Penumbra. G. Colby: 2; C; Medtronic, Stryker, Microvention. C. Schirmer: 1; C; NIH/NINDS. 6; C; AANS Honoraria, Ownership- NTI. B. Pukenas: 1; C; Stryker Neurovascular. S. Satti: 2; C; Stryker Neurovascular, Penumbra, Cerenovus, Terumo. 6; C; Medtronic – Proctor. T. Miller: None. D. Gandhi: 1; C; Stryker Neurovascular.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.