Table 3.
Baseline target lesion characteristics | Site-reported (N = 169) | Core laboratory-reported (N = 168a) |
---|---|---|
Lesion length (mm) | 43.4 ± 30.5 (169) | 39.0 ± 27.0 (168) |
Preprocedure reference vessel diameter (mm) | 5.5 ± 0.7 (169) | 4.9 ± 0.9 (168) |
Preprocedure minimum lumen diameter (mm) | Not reported | 1.1 ± 0.8 (168) |
Preprocedure diameter stenosis (%) | 88.3 ± 8.5 (169) | 76.5 ± 15.4 (168) |
Occlusion | 9.5% (16/169) | 17.9% (30/168) |
Arterial Segment Treated | ||
Proximal superficial femoral artery | 11.8% (20/169) | 14.3% (24/168) |
Mid superficial femoral artery | 38.5% (65/169) | 31.5% (53/168) |
Distal superficial femoral artery | 36.1% (61/169) | 43.5% (73/168) |
Proximal popliteal | 8.3% (14/169) | 9.5% (16/168) |
Mid/distal popliteal | 5.3% (9/169) | 1.2% (2/168) |
Type of lesion | ||
Restenotic | 12.4% (21/169) | Not reported |
De Novo | 87.6% (148/169) | Not reported |
Lesion Eccentricity | ||
Concentric/none | 18.3% (31/169) | 41.7% (70/168) |
Eccentric | 81.7% (138/169) | 58.3% (98/168) |
Calcification | ||
None/Mild | 0% (0/169) | 6.0% (10/168) |
Moderate | 47.9% (81/169) | 13.1% (22/168) |
Severe | 52.1% (88/169) | 81.0% (136/168) |
Per angiographic core laboratory assessment there were 168 lesions; in one subject, the site reported two discrete lesions while the angiographic core laboratory reported a single diffuse lesion.