Details of the procedures and end points (all 10 patients)
Femoral access, n | 7 |
Radial access, n | 3 |
Aortic arch type 1 | 5 |
Aortic arch type 2 | 3 |
Aortic arch: bovine | 2 |
Target vessel diameter, mean (± SD) mm | 4.2 (± 0.6) |
Successful navigation to target vessel, n | 10 (100%) |
Adjunctive/rescue device needed (wire/balloon/other catheter) | 0 (0%) |
Total access time, mean (range) min | 22.5 (13–45) |
Navigation time from puncture site to target vessel with GC and G60 device, mean (range) min | 8 (4–17) |
Overall procedure time, mean (range) min | 96 (25–172) |
Procedural AE (including access site), n | 0 |
Procedural SAE, n | 1 |
G60-related AE, n | 0 |
G60-related SAE, n | 0 |
Postprocedure AE, n | 0 |
Postprocedure SAE, n | 0 |
Note:—AE indicates adverse event; SAE, severe adverse event.