Table 3: Key effectiveness results.

MeasureMeasure of success
(%)
[95% CI]

Primary endpoint
 Adequacy of palliation54 (98.2%)[90.3%, 100%]*
Secondary endpoints
 Stent deployment/technical success57 (98.3%)[90.8%, 100%]
 Number of biliary obstructive symptoms at baseline
  Mean ± SD ( ) [2.0, 3.50]
  Range (Min, Max)(1, 8)
  Median2
 Number of biliary obstructive symptoms at month 6
  Mean ± SD ( ) [0.00, 0.33]
  Range (Min,Max)(0, 2)
  Median0
 Stent patency21 (91.3%)[72.0%, 98.9%]
 Reduction of bilirubin level at month 144 (97.8%)[88.2%, 99.9%]

Intent-to-treat (58).