First-in-human trial of Stabilizer device in neuroendovascular therapy
Chiaki Sakai,
Nobuyuki Sakai,
Ariel Takayanagi,
Hirotoshi Imamura,
Tsuyoshi Ohta,
Masaomi Koyanagi,
Masanori Goto,
Ryu Fukumitsu,
Tadashi Sunohara,
Nobuyuki Fukui,
Shirabe Matsumoto,
Tomoaki Akiyama,
Yuki Takano,
Hironori Haruyama,
Koichi Go,
Shinji Kajiura,
Masashi Shigeyasu,
Kento Asakura,
Ryo Horii,
Yuji Naramoto,
Rikuo Nishii,
Yasuhiro Yamamoto,
Kunimasa Teranishi,
Satohiro Kawade,
Taichiro Imahori,
Naoki Kaneko,
Satoshi Tateshima
Affiliations
Chiaki Sakai
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; Corresponding author. Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital. 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Nobuyuki Sakai
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
Ariel Takayanagi
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
Hirotoshi Imamura
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Tsuyoshi Ohta
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Masaomi Koyanagi
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Masanori Goto
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Ryu Fukumitsu
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Tadashi Sunohara
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Nobuyuki Fukui
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Shirabe Matsumoto
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Tomoaki Akiyama
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Yuki Takano
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Hironori Haruyama
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Koichi Go
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Shinji Kajiura
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Masashi Shigeyasu
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Kento Asakura
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Ryo Horii
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Yuji Naramoto
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Rikuo Nishii
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Yasuhiro Yamamoto
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Kunimasa Teranishi
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Satohiro Kawade
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan
Taichiro Imahori
Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA
Naoki Kaneko
Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA
Satoshi Tateshima
Division of Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA
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.
