TY - JOUR
T1 - Target Ultra and Nano coils in the endovascular treatment of small intracranial aneurysms (ULTRA Registry)
AU - ULTRA Study Investigators
AU - Jindal, Gaurav
AU - Almardawi, Ranyah
AU - Gupta, Rishi
AU - Colby, Geoffrey P.
AU - Schirmer, Clemens M.
AU - Satti, Sudhakar R.
AU - Pukenas, Bryan
AU - Hui, Ferdinand K.
AU - Caplan, Justin
AU - Miller, Timothy
AU - Cherian, Jacob
AU - Aldrich, Francois
AU - Kibria, Gulam
AU - Simard, J. Marc
N1 - Funding Information:
This registry was funded by Stryker Neurovascular. The sponsor had no role in data collection, data management, data analysis, nor manuscript preparation. Dr. Jindal reports receiving clinical or research support for the study described (includes equipment or material) from, being a consultant for, and receiving support for travel and food from Stryker Neurovascular and receiving clinical or research support for the study described from MicroVention. Drs. Gupta and Satti each report being a consultant for Stryker Neurovascular. Dr. Colby reports being a consultant for Stryker Neurovascular and MicroVention. Dr. Caplan reports being a consultant for Medtronic, receiving clinical or research support for the study described (includes equipment or material) from Stryker, and receiving support of non–study-related clinical or research effort overseen by the author from MicroVention, Balt, and Stryker. Dr. Miller reports receiving clinical or research support for the study described (includes equipment or material) from Stryker and being a site investigator and receiving salary support from MicroVention-Terumo, Vesalio, Stryker, and Northwestern University for the completed Hydrogel Endovascular Aneurysm Treatment Trial (HEAT), a multicenter study investigating the safety and efficacy of using hydrogel-coated coils for the treatment of intracranial aneurysms.
Publisher Copyright:
© 2023 The authors.
PY - 2023/1
Y1 - 2023/1
N2 - 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.
AB - 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.
KW - Nano
KW - Target
KW - Ultrasoft
KW - aneurysm
KW - coil
KW - embolization
KW - endovascular neurosurgery
KW - vascular disorders
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U2 - 10.3171/2022.5.JNS2296
DO - 10.3171/2022.5.JNS2296
M3 - Article
C2 - 35901755
AN - SCOPUS:85145425207
SN - 0022-3085
VL - 138
SP - 233
EP - 240
JO - Journal of neurosurgery
JF - Journal of neurosurgery
IS - 1
ER -