Table 2.
Anatomic Characteristicsa
| Variable | N=202/241 Lesions |
|---|---|
| Preprocedure | |
| De novo lesions | 100% (241/241) |
| Unilateral lesions | 67.6% (163/241) |
| Bilateral lesions | 32.4% (78/241) |
| Site‐reported diameter stenosis, % | 81.3±10.0 |
| Core laboratory–reported diameter stenosis, % | 65.9±11.4 |
| Core laboratory–reported minimum lumen diameter, mm | 1.8±0.7 |
| Core laboratory–reported reference vessel diameter, mm | 5.4±1.1 |
| Lesion length, mm | 8.5±3.1 |
| Heavy calcification | 27.8% (67/241) |
| Suboptimal PTA outcome | |
| Residual stenosis ≥50% | 90.7% (214/236) |
| 10 mm Hg mean gradient or 20 mm Hg peak systolic gradient across the lesion | 25.0% (59/236) |
| Flow‐limiting dissection (NHLBI grade D) or TIMI flow <3 | 4.7% (11/236) |
| Postprocedure | |
| Core laboratory–reported diameter stenosis,% | 3.4±12.5 |
| Core laboratory–reported minimum lumen diameter, mm | 5.1±0.8 |
| Study device success | 96.0% (237/247) |
| Procedure success | 99.2% (238/240) |
| Clinical success | 98.0% (197/201) |
a
Abbreviations: NHLBI, National Heart, Lung, and Blood Institute; PTA, percutaneous transluminal angioplasty; TIMI, thrombolysis in myocardial infarction. Per lesion.