RT Journal Article
SR Electronic
T1 ACCESS: ACtive Catheterization for EndovaScular TreatmentS—A First-in-Human, Single-Center, Nonrandomized, Open Clinical Study of the G60 Active Device for Endovascular Neurointerventions
JF American Journal of Neuroradiology
JO Am. J. Neuroradiol.
FD American Society of Neuroradiology
DO 10.3174/ajnr.A8345
A1 Escalard, Simon
A1 Al-Raaisi, Amira
A1 Désilles, Jean-Philippe
A1 Redjem, Hocine
A1 Smajda, Stanislas
A1 Lahlouh, Mounir
A1 Delvoye, François
A1 Boisseau, William
A1 Mazighi, Mikaël
A1 Piotin, Michel
YR 2024
UL http://www.ajnr.org/content/early/2024/08/08/ajnr.A8345.abstract
AB The catheterization of supra-aortic vessels during neuroendovascular interventions may be challenging in the setting of complex aortic arch anatomy. Evaluation of a new mechatronic controllable directional device in conjunction with different sheath and guide catheters to ease the cannulation of the supra-aortic vessels was conducted in the setting of a first-in-human clinical study. The evaluation assessment included access to the aortic arch, the technical success of the device in terms of time to target vessel, target vessel catheterization, adverse events, and clinical outcome. Ten subjects were enrolled at 1 site for treatment. Successful access, target vessel catheterization, and correct positioning of the catheter into the target vessel with the G60 device were achieved for all 10 procedures (7 from femoral access, 3 from radial access). One procedural complication, unrelated to the G60 device, was recorded during the investigation. The G60 is a polyvalent active device that facilitates guide catheter navigation in neuroendovascular interventions.DSMBdata and safety monitoring boardFIHfirst-in-humanGCguide catheterSAVsupra-aortic vessel