Secondary efficacy endpoints at 12-month follow-up
| Endpoint | Summary statistics (n=116) | 95% CI |
| Procedural technical success (per patient) | 116/116 (100.0%) | |
| Subjects with one stent implanted | 76/116 (65.5%) | |
| Subjects with two stents implanted | 40/116 (34.5%) | |
| Raymond-Roy class (core laboratory) | ||
| I | 81/95 (85.3%) | (76.5% to 91.7%) |
| II | 9/95 (9.5%) | (4.4% to 17.2%) |
| III | 5/95 (5.3%) | (1.7% to 11.9%) |
| 1 and 2 combined | 90/95 (94.7%) | (88.1% to 98.3%) |
| Recanalization (1) | 9/97 (9.3%) | (4.3% to 16.9%) |
| Any Raymond-Roy class change over time (core laboratory) | ||
| Same | 68/95 (71.6%) | (61.4% to 80.4%) |
| Better | 17/95 (17.9%) | (10.8% to 27.1%) |
| Worse | 10/95 (10.5%) | (5.2% to 18.5%) |
| Parent artery stenosis >50% (core laboratory) | 2/95 (2.1%) | (0.3% to 7.4%) |
| Incidence of stent migration (core laboratory) | 0/95 (0.0%) | (0.0% to 3.8%) |
| Incidence of re-treatment (site-reported) | 9/116 (7.8%) | (3.6% to 14.2%) |
Data are n (%).
*Recanalization is defined as Raymond score of 3 at 12 month visit or retreatment due to recanalization.