Table 2.
6-month angiographic results.
| Parameters | FAS | PPS |
|---|---|---|
| 101 Subjects/104 Lesions | 81 Subjects/82 Lesions | |
| Reference vessel diameter, mm | 3.50 ± 0.56 | 3.50 ± 0.57 |
| Minimum luminal diameter, mm | 2.63 ± 0.69 | 2.65 ± 0.66 |
| Percentage diameter stenosis | 25.1 ± 17.1 | 24.4 ± 16.1 |
| In-stent stenosis (Lesion level) | 5 (5.9) | 3 (3.7) |
| In-stent stenosis (Patient level) | 5 (6.0) | 3 (3.7) |
Values are mean ± SD or n (%); FAS, Full Analysis Set; PPS, Per Protocol Set; In-stent stenosis = percentage diameter stenosis ≥ 50%; Percentage diameter stenosis = (1–[DStenosis/DDistal]) × 100%; 6-month angiographic results analyzed on Core-lab data.