First-in-human trial of Stabilizer device in neuroendovascular therapy.

Autor:	Sakai C; Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital, Kobe, Japan.; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Sakai N; Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital, Kobe, Japan.; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Takayanagi A; Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.; Department of Neurological Surgery, Riverside University Health System, Moreno Valley, CA, USA., Imamura H; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Ohta T; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Koyanagi M; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Goto M; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Fukumitsu R; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Sunohara T; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Fukui N; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Matsumoto S; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Akiyama T; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Takano Y; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Haruyama H; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Go K; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Kajiura S; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Shigeyasu M; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Asakura K; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Horii R; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Naramoto Y; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Nishii R; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Yamamoto Y; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Teranishi K; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Kawade S; Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan., Imahori T; Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA., Kaneko N; Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA., Tateshima S; Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA.
Jazyk:	angličtina
Zdroj:	Heliyon [Heliyon] 2023 Mar 11; Vol. 9 (3), pp. e14360. Date of Electronic Publication: 2023 Mar 11 (Print Publication: 2023).
DOI:	10.1016/j.heliyon.2023.e14360
Abstrakt:	Objectives: Flow diverter or stent implantation to intracranial target lesion requires large inner diameter microcatheter navigation. The exchange method using stiff long wire is often necessary if it is difficult to navigate over the regular guidewire. However, this method has an intrinsic risk of vessel damage and may cause severe complications. We investigated the safety and efficacy of a new device, the Stabilizer device for navigation in a first-in-human clinical trial under the Certified Review Board agreement. Materials and Methods: The Stabilizer is a 320 cm length exchange wire with a stent for anchoring and is compatible with a 0.0165" microcatheter. The trial design is a prospective single-arm open-label registry. Inclusion criteria are elective flow diverter treatment or stent-assisted coiling, expected to be difficult to navigate a microcatheter with a regular micro guidewire, and obtained documented consent. The primary endpoint of the study was a hemorrhagic complication. Results: Five patients were enrolled in this trial. The median age is 52 years, ranges from 41 to 70, and all patients were female. Three aneurysms were located on the internal carotid artery, one on the vertebral artery, and one on the basilar artery. Basilar artery aneurysm was treated by stent-assisted coiling and others were treated by flow diverter deployment. All cases successfully navigate microcatheter for the treatment by the trial method using Stabilizer device without any adverse event. Conclusions: The results from this first-in-human consecutive five cases show the safety of the Stabilizer device in neuro-endovascular therapy for navigation of devices to the intracranial target lesion. Competing Interests: The authors declare the following conflict of interests: This trial received trial devices from Bolt Medical, without specific grant. Grant from Kobe City Medical Center General Hospital support this trial. The authors, NS, NK and ST, were consultants of Bolt Medical at the treatment, but declare that this trial was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest. 10.13039/100007057NS received a research grant from Biomedical Solutions, 10.13039/501100002973Daiichi-Sankyo, and Terumo; lecturer's fees from Asahi-Intec, Biomedical Solutions, 10.13039/501100002973Daiichi-Sankyo, and Medtronic; membership on the advisory boards for Johnson&Johnson, 10.13039/100004374Medtronic and 10.13039/501100008645Terumo without related this manuscript. HI received lecturer's fee from 10.13039/100004374Medtronic. NK has been a consultant for Stryker and Medtronic. 10.13039/501100004347ST received research funds from Biomedical Solutions, Rapid Medical and Medtronic, and a consultant for TG Medical, 10.13039/100008476Irvine Neurovascular, Balt USA, Cerenovus, 10.13039/100004374Medtronic, Phenox GmbH, MicroVention, Kaneka USA, Century Medical Inc., EnCompass, NVMedTech, and 10.13039/100008894Stryker. The other authors have no personal or financial interest in any of the materials or devices described in this article. (© 2023 The Author(s).)
Databáze:	MEDLINE
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