Table 2

Effectiveness outcomes

ParameterProximal (ICA) groupDistal (non-ICA) groupP 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
 155/62 (88.7)80/91 (87.9)
 24/62 (6.5)8/91 (8.8)
 33/62 (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
 Same37/62 (59.7)55/91 (60.4)
 Better23/62 (37.1)30/91 (33.0)
 Worse2/62 (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/A, not available.