Table 3 Procedural effectiveness endpoints
Primary Effectiveness Endpoints | UFE (n = 70) | PAE (n = 16) | LT (n = 7) | OHT (n = 6) | All Subjects (n = 99) |
|---|---|---|---|---|---|
Procedure Successa | 100% | 100% | 100% | 100% | 100% |
Radial-to-femoral Conversion | 0% | 0% | 0% | 0% | 0% |
Technical Successb | |||||
Complete | 98.6% | 87.5% | 100% | 100% | 97.0% |
Incomplete | 1.4% | 12.5% | 0.0% | 0.0% | 3.0% |
Secondary Effectiveness Endpoints | |||||
Time to hemostasisc(n) | 1:52 ± 0.47 (68) | 2:14 ± 0.31 (16) | 2:52 ± 0.56 (7) | 2:13 ± 0.36 (4) | 2:01 ± 0:48 (95) |
Time to ambulationc(n) | 3:34 ± 1:36 (69) | 3:51 ± 1:30 (16) | 4:05 ± 1:36 (7) | 4:24 ± 2:07 (5) | 3:42 ± 1:36 (97) |
Time to dischargec(n) | 12:48 ± 26:28 (70) | 4:43 ± 1:02 (16) | 12:41 ± 17:00 (7) | 37:34 ± 53:45 (6) | 12:59 ± 26:35 (99) |
Procedure Lengthc(n) | 1:28 ± 0.40 (70) | 2:12 ± 0:51 (16) | 1:14 ± 0:24 (7) | 1:16 ± 0:38 (6) | 1:33 ± 0:44 (99) |
Contrast volume used mLc(n) | 119.3 ± 59.8 (70) | 149.3 ± 72.0 (16) | 93.1 ± 26.8 (7) | 100.0 ± 66.6 (6) | 123.5 ± 61.9 (99) |
Total Blood Loss (> 5 cc) | 0% | 0% | 0% | 0% | 0% (99) |