Table 6

Residual Defect Status

12 Months
(Days 245–548)
24 Months
Optional
(Days 549–912)
36 Months
(Days 913–1,276)
48 Months
Optional
(Days 1,277–1,641)
60 Months
(Days 1,642–2,006)
Patients with successful delivery137137137137137
Patients with core laboratory review11716652079
 Completely occluded82 (70.1)8 (50.0)52 (80.0)12 (60.0)58 (73.4)
 Clinically insignificant leak34 (29.1)8 (50.0)13 (20.0)8 (40.0)21 (26.6)
 Clinically significant leak1 (0.9)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Patients missing core laboratory review201217211758
 Discontinued study before evaluation12 (60.0)28 (23.1)35 (48.6)37 (31.6)44 (75.9)
 Core laboratory review not completed8 (40.0)93 (76.9)37 (51.4)80 (68.4)14 (24.1)

Values shown are number or number (%).