Table 4

Primary effectiveness (complete aneurysm occlusion with no significant stenosis and no re-treatment) and alternative definition of effectiveness (near-complete aneurysm occlusion with no significant stenosis and no re-treatment) intention-to-treat population

Endpointn=139
n (%)
Posterior mean
(95% CI)
Posterior probability*
Primary effectiveness80 (57.6%)57.4% (49.2% to 65.5%)0.997
Primary effectiveness components:
 Aneurysm occlusion (Raymond 1) (n=140)†88 (62.9%)62.7% (54.6% to 70.4%)
 Absence of clinically significant stenosis of parent artery (≥50%) (n=139)133 (95.7%)95.0% (90.9% to 98.0%)
 No re-treatment (n=140)†132 (94.3%)93.7% (89.1% to, 97.0%)
Primary effectiveness, alternative definition100 (71.9%)71.6% (63.9% to 78.7%)>0.999
Primary effectiveness components:
 Aneurysm occlusion (90% occlusion or
 greater) (n=140)†
112 (80.0%)79.6% (72.6% to 85.8%)
 Absence of clinically significant stenosis
 of parent artery (≥50%) (n=139)
133 (95.7%)95.0% (90.9% to 98.0%)
 No re-treatment (n=140)†132 (94.3%)93.7% (89.1% to 97.0%)
  • *Posterior probability that the primary efficacy endpoint success rate is >46%.

  • †One subject was assessed for aneurysm occlusion but not stenosis of the parent artery.