Table 2. Effectiveness outcomes.
Parameter | Proximal (ICA) group | Distal (non-ICA) group | P value |
Primary efficacy endpoint, n (%) | 53/62 (85.5) | 78/93 (83.9) | 0.78 |
Secondary efficacy endpoints | |||
Raymond Class (core lab), n (%) | 0.78 | ||
1 | 55/62 (88.7) | 80/91 (87.9) | |
2 | 4/62 (6.5) | 8/91 (8.8) | |
3 | 3/62 (4.8) | 3/91 (3.3) | |
Raymond Class 1 and 2 combined, n (%)* | 59/62 (95.2) | 88/91 (96.7) | 0.65 |
Recanalization, n (%)† | 4/62 (6.5) | 5/92 (5.4) | 0.76 |
Progressive occlusion of target aneurysm (core lab), n (%) | 0.61 | ||
Same | 37/62 (59.7) | 55/91 (60.4) | |
Better | 23/62 (37.1) | 30/91 (33.0) | |
Worse | 2/62 (3.2) | 6/91 (6.6) | |
Parent artery stenosis >50% (core lab), n (%) | 1/62 (1.6) | 1/91 (1.1) | 0.78 |
Incidence of stent migration (core lab), n (%) | 0/68 (0.0) | 0/112 (0.0) | N/A |
Incidence of retreatment (site-reported), n (%)‡ | 2/70 (2.9) | 5/112 (4.5) | 0.55 |
Composite outcome: complete aneurysm occlusion (100% occlusion – Raymond Class 1) of the treated target lesion on 12-month angiography, in the absence of retreatment, or parent artery stenosis (>50%) at the target location, and no neurological death.
Recanalization is defined as a Raymond score of 3 at 12-month visit or retreatment due to recanalization.
Two of the seven subjects had pre-planned staged procedures.
N/Anot available