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
Endpoint | n=139 n (%) | Posterior mean (95% CI) | Posterior probability* |
Primary effectiveness | 80 (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 definition | 100 (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.