マイクロRNAスイッチを用いた胎児幹細胞由来神経細胞からの皮質投射ニューロンの選別法の開発

京都大学0048新制・課程博士博士(医学)甲第22340号医博第4581号新制||医||1042(附属図書館)京都大学大学院医学研究科医学専攻(主査)教授 影山 龍一郎, 教授 井上 治久, 教授 上杉 志成学位規則第4条第1項該当Doctor of Medical ScienceKyoto UniversityDFA

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

ObjectivesFlow 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 methodsThe 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.ResultsFive 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.ConclusionsThe 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