Randomized Treatment | ||||
---|---|---|---|---|
Hydrogel | Bare Platinum | |||
No. | % | No. | % | |
Total No. patients randomized | 249 | 250 | ||
Sex | ||||
Female | 176 | 70.7 | 174 | 69.6 |
Male | 73 | 29.3 | 76 | 30.4 |
Age (years) | ||||
<45 | 80 | 32.1 | 78 | 31.2 |
46–55 | 68 | 27.3 | 75 | 30.0 |
>55 | 101 | 40.6 | 97 | 38.8 |
Target aneurysm size (maximal dimension) | ||||
2–4.9 mm | 42 | 16.9 | 41 | 16.4 |
5–9.9 mm | 144 | 57.8 | 144 | 57.6 |
10–24.9 mm | 63 | 25.3 | 65 | 26.0 |
Dome-to-neck ratio | ||||
<1.5 | 83 | 33.3 | 81 | 32.4 |
>1.5 | 166 | 66.7 | 169 | 67.6 |
Baseline rupture status | ||||
Yes, in previous 30 days | 132 | 53.0 | 133 | 53.2 |
Yes, >30 days ago | 5 | 2.0 | 4 | 1.6 |
Yes, but date unknown | 2 | 0.8 | 1 | 0.4 |
No | 110 | 44.2 | 112 | 44.8 |
Aneurysm shape | ||||
Irregular (multilobulated) | 76 | 30.5 | 77 | 30.8 |
Not multilobulated | 173 | 69.5 | 173 | 69.2 |
Planned use of assist device | ||||
Yes | 112 | 45.0 | 115 | 46.0 |
No | 122 | 49.0 | 121 | 48.4 |
Missing (see “Results”) | 15 | 6.0 | 14 | 5.6 |
Assist device actually used * | 116 | 46.6 | 115 | 46.0 |
Balloon | 65 | 26.1 | 60 | 24.0 |
Stent | 46 | 18.5 | 52 | 20.8 |
Other (TriSpan† double microcatheter techniques) | 3 | 1.2 | 3 | 1.2 |
Assist device attempted but failed | 2 | 0.8 | 0 | 0 |
Not known (consent withdrawn) | 1 | 0.4 | 0 | 0 |
None | 131 | 137 | ||
Randomized Americas‡ | ||||
Yes | 89 | 35.7 | 89 | 35.6 |
No | 160 | 64.3 | 161 | 64.4 |
* More than 1 assist device may have been used in any individual case.
† Boston Scientific, Natick, Mass.
‡ This is North and South America combined.