Objective: The ULTRA Registry is a national multicenter prospective study designed to assess aneurysm occlusion rates and safety profiles of the Target Ultra and Nano coils in the treatment of small intracranial aneurysms (IAs).
Methods: Patients with small (≤ 5 mm) ruptured and unruptured IAs were treated exclusively with Target Ultra and Nano coils. The primary endpoints were the initial rate of complete or near-complete aneurysm occlusion, aneurysm recurrence, and need for retreatment. Secondary endpoints were device- and procedure-related adverse events, hemorrhage from the coiled aneurysm at any time during follow-up, and clinical outcomes.
Results: The ULTRA Registry included 100 patients with a mean ± SD age of 56 ± 11.6 years, of whom 75 were women and 48 presented after aneurysm rupture. The mean aneurysm size was (3.5 ± 0.9) × (2.8 ± 0.9) × (3.0 ± 1.0) mm, and the mean packing density was 34.4% ± 16.7%. Posttreatment complete or near-complete occlusion reported by an independent imaging core laboratory was seen in 92% of patients at baseline and in 87%, 87%, and 83% of patients at first, second, and final follow-up, respectively. At first, second, and final follow-up, 10%, 11%, and 15%, respectively, of patients were deemed to require retreatment. There were three procedural-related ischemic strokes and one intracranial hemorrhage from wire perforation of a parent artery not involved by the aneurysm. There were no coil-related adverse events, including no intraoperative aneurysm ruptures and no known aneurysm ruptures after coiling.
Conclusions: This assessment of aneurysm occlusion rates and safety profiles in ULTRA Registry study participants demonstrates excellent safety and efficacy profiles for Target Ultra and Nano coils in the treatment of small IAs.
Trial registration: ClinicalTrials.gov NCT02657772.
Keywords: Nano; Target; Ultrasoft; aneurysm; coil; embolization; endovascular neurosurgery; vascular disorders.