1. Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: the coil-assisted flow diversion safety and performance study (CAFI).
- Author
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Liebig T, Gal G, O Kelly C, Wodarg F, Killer-Oberpfalzer M, Ozpeynirci Y, Bester M, Tsogkas I, Psychogios MN, Jansen O, and Fiehler J
- Subjects
- Humans, Male, Middle Aged, Female, Aged, Prospective Studies, Treatment Outcome, Stents, Adult, Endovascular Procedures methods, Endovascular Procedures instrumentation, Endovascular Procedures adverse effects, Follow-Up Studies, Embolization, Therapeutic instrumentation, Embolization, Therapeutic methods, Embolization, Therapeutic adverse effects, Intracranial Aneurysm therapy, Intracranial Aneurysm surgery, Intracranial Aneurysm diagnostic imaging
- Abstract
BackgroundThe Neqstent coil-assisted flow diverter (NQS) is a neck bridging device to facilitate coil occlusion of intracranial aneurysms. CAFI is a prospective, single-arm, multicenter study on the safety and performance of the NQS adjunctive therapy device together with platinum coils for treatment of unruptured intracranial aneurysms., Methods: Thirty-eight patients were enrolled. Primary endpoints were occlusion at 6 months for efficacy, and any major stroke or non-accidental death up to 30 days or major disabling stroke within 6 months for safety. Secondary endpoints were re-treatment rate, procedure time, and procedure/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee., Results: The NQS was successfully implanted in 36/38 aneurysms, 2/38 in the intention-to-treat group did not receive a NQS and were excluded from follow-up after 30 days. In the per protocol group (PP), 33/36 patients were available for angiographic follow-up. Device related adverse events were recorded in 4/38 (10.5%) patients, one hemorrhagic and three thromboembolic. In the PP group, immediate post-treatment adequate occlusion (RR1 and RR2) was seen in 9/36 (25%) and progressed to 28/36 (77.8%) at 6 months. Complete occlusion (RR1) was achieved in 29/36 (80.6%) at the last available angiogram (3/36 were post procedure). The mean procedure time was 129 min (50-300 min, median 120 min)., Conclusion: The NQS in conjunction with coils appears to be effective in the treatment of intracranial wide-neck bifurcation aneurysms, but its safety remains to be proved in larger series., Trial Registration Number: NCT04187573., Competing Interests: Competing interests: TL proctors and consults for CERUS Medical, Inc. and has in the past 3 years received service-related fees from Stryker, Acandis, Microvention, Medtronic, Pfizer, Balt, and Cercare; GG proctors and consults for CERUS Endovascular; COK has no conflict of interest; FW proctors and consults for Cerus Endovascular, outside this study and within the past 3 years he has proctored or received service-related fees from MicroVention, Acandis, Cerenovus, Route 92, and Daiichi Sankyo; IT has no conflict of interest; M-NP has no conflict of interest, YO has no conflict of interest; JF receives research support from EU, BMBF, BMWi, DFG, Acandis, Medtronic, Microvention, Stryker, holds an executive function at Eppdata and stock in Tegus. He consults for Acandis, Cerenovus, Medtronic, Microvention, Penumbra, Phenox, and Stryker and is acting as a member of the editorial board of JNIS; MK-O consults for Cerus Endovascular, outside this study and within the past 3 years she has received service-related fees from MicroVention, Medtronic and Stryker; MB has no conflict of interest; OJ receives research support from BMBF and DFG. During the past 3 years he consulted for Acandis, Cerenovus, Cerus Endovascular, Microvention, Philips, Radiologie Holding, Route 92, and Stryker., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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