Table 1

Primary efficacy endpoint and occlusion assessment at 12 months

UnrupturedRupturedTotal
Primary efficacy endpointn=93n=53n=146
 Raymond I52 (55.9%)38 (71.1%)90 (61.6%)
 Raymond II23 (24.7%)7 (13.2%)30 (20.5%)
 Raymond III18* (19.4%)8† (15.1%)26‡ (17.8%)
 Adequate occlusion without re-treatment75 (80.6%)45 (84.9%)120 (82.2%)
Occlusion assessment at 12 monthsn=91n=52n=143
 Raymond I52 (57.1%)38 (73.1%)90 (62.9%)
 Raymond II23 (25.3%)7 (13.5%)30 (21.0%)
 Raymond III16 (17.6%)7 (13.5%)23 (16.1%)
 Adequate occlusion75 (82.4%)45 (86.5%)120 (83.9%)
  • Primary efficacy endpoint consists of occlusion rate with no re-treatment at the 12 months' follow-up; for re-treated patients, occlusion rate was assessed at the time of re-treatment.

  • Occlusion assessment at the 12 months' follow-up is a secondary endpoint and does not include re-treated patients.

  • *Including two subjects re-treated.

  • †Including one subject re-treated.

  • ‡Including three subjects re-treated.