Table 2

Core Laboratory angiographic and Clinical Event Committee safety primary endpoints

Core laboratory angiographic occlusion findingsPost-procedure12 Months12 Months
n=30 (95% CI)n=27 (95% CI)n=30 (95% CI)
By available angiographyImputed by LOCF*
Raymond class
 Complete 100% occlusion (Class I)60.0% (18/30) (40.6% to 77.3%)92.6% (25/27) (75.7% to 99.1%)86.7% (26/30) (69.3% to 96.2%)
 With no stenosis (≤50%)60.0% (18/30) (40.6% to 77.3%)88.9% (24/27) (70.8% to 97.6%)83.3% (25/30) (65.3% to 94.4%)
 Residual neck† (Class II)26.7% (8/30) (12.3% to 45.9%)0.0% (0/27) (0.0% to 12.8%)0.0% (0/30) (0.0% to 11.6%)
 Residual aneurysm‡ (Class III)10.0% (3/30) (2.1% to 26.5%)7.4% (2/27) (0.9% to 24.3%)10.0% (3/30) (2.1% to 26.5%)
 Not assessable3.3% (1/30) (0.1% to 17.2%)0.0% (0/27) (0.0% to 12.8%)3.3% (1/30) (0.1% to 17.2%)
Parent artery stenosis
 0–25%100.0% (30/30) (88.4% to 100.0%)96.3% (26/27) (81.0% to 99.9%)93.3% (28/30) (77.9% to 99.2%)
 26–50%0.0% (0/30) (0.0% to 11.6%)0.0% (0/27) (0.0% to 12.8%)3.3% (1/30) (0.1% to 17.2%)
 51–70%0.0% (0/30) (0.0% to 11.6%)0.0% (0/27) (0.0% to 12.8%)0.0% (0/30) (0.0% to 11.6%)
 71–99%0.0% (0/30) (0.0% to 11.6%)3.7% (1/27) (0.1% to 19.0%)3.3% (1/30) (0.1% to 17.2%)