Table IV.
Summary of quantitative optical coherence tomography (OCT) results
| EVSS (n = 8) |
||||||
|---|---|---|---|---|---|---|
| Post-procedure | 30 days | 90 days | 180 days | 365 days | 730 days | |
| Mean scaffold/stent diameter, mm | 5.18 ± 0.68 | 5.50 ± 0.52 | 5.47 ± 0.56 | 5.73 ± 0.63 | 6.21 ± 0.95 | 6.29 ± 0.92 |
| Mean lumen diameter, mm | 4.67 ± 0.65 | 4.84 ± 0.49 | 4.59 ± 0.55 | 4.67 ± 0.67 | 5.28 ± 1.00 | 5.39 ± 0.77 |
| Mean neointimal thickness, mm | 0.25 ± 0.03 | 0.33 ± 0.03 | 0.44 ± 0.07 | 0.53 ± 0.07 | 0.47 ± 0.08 | 0.45 ± 0.12 |
| Mean diameter stenosis, % | 9.9 ± 1.0% | 12.1 ± 1.2% | 16.4 ± 2.8% | 18.7 ± 3.2% | 15.4 ± 3.3% | 14.3 ± 2.7% |
| Mean scaffold/stent area, mm2 | 21.4 ± 5.9 | 24.0 ± 4.7 | 23.9 ± 5.2 | 26.1 ± 5.9 | 31.2 ± 10.3 | 32.1 ± 9.5 |
| Mean Lumen Area, mm2 | 17.5 ± 5.1 | 18.6 ± 4.0 | 16.9 ± 4.4 | 17.6 ± 5.2 | 22.8 ± 9.6 | 23.6 ± 6.8 |
| Mean neointimal area, mm2 | 3.96 ± 0.84 | 5.47 ± 0.92 | 7.00 ± 1.35 | 8.60 ± 1.32 | 8.52 ± 1.53 | 8.41 ± 3.35 |
| Mean area stenosis, % | 18.8 ± 1.9% | 22.7 ± 2.1% | 30.0 ± 4.6% | 33.7 ± 5.2% | 28.3 ± 5.7% | 26.5 ± 4.7% |
| SES (n = 8) |
||||||
|---|---|---|---|---|---|---|
| Post-procedure | 30 Days | 90 Days | 180 days | 365 days | 730 days | |
| Mean scaffold/stent diameter, mm | 5.41 ± 0.57 | 6.49 ± 0.57 | 6.72 ± 0.27 | 6.89 ± 0.40 | 7.18 ± 0.39 | 7.34 ± 0.47 |
| Mean lumen diameter, mm | 4.90 ± 0.56 | 4.50 ± 0.86 | 3.65 ± 1.79 | 4.04 ± 1.95 | 4.39 ± 1.96 | 4.73 ± 2.11 |
| Mean neointimal thickness, mm | 0.26 ± 0.04 | 0.99 ± 0.27a | 1.54 ± 0.78a | 1.42 ± 0.86a | 1.40 ± 0.89a | 1.31 ± 0.91a |
| Mean diameter stenosis, % | 9.6 ± 1.4% | 31.0 ± 9.1%a | 46.5 ± 25.0%a | 42.2 ± 26.0%a | 39.6 ± 25.8%a | 36.5 ± 26.8%a |
| Mean scaffold/stent area, mm2 | 23.3 ± 5.1 | 33.5 ± 5.9a | 35.7 ± 2.9a | 37.5 ± 4.6a | 40.7 ± 4.5a | 42.6 ± 5.6a |
| Mean lumen area, mm2 | 19.1 ± 4.4a | 16.6 ± 6.2 | 12.9 ± 8.9 | 15.8 ± 10.9 | 18.0 ± 10.0 | 20.7 ± 11.6 |
| Mean neointimal area, mm2 | 4.17 ± 0.90 | 16.85 ± 4.25a | 22.79 ± 6.19a | 21.79 ± 7.39a | 22.79 ± 7.52a | 21.86 ± 7.37a |
| Mean area stenosis, % | 18.2 ± 2.6% | 51.1 ± 13.0%a | 65.5 ± 21.4%a | 60.3 ± 22.6% | 57.4 ± 20.9%a | 53.3 ± 22.1%a |
EVSS, Efemoral Vascular Scaffold System; SES, self-expanding stents
Values are mean ± standard deviation.
P < .05 compared with EVSS.