Primary endpoint | Frequency | 95% CI | |
Non-MAE rate | 98.6% | 94.4% to 99.6% | |
Secondary efficacy endpoint | |||
Treatment success | 87.9% | 81.2% to 92.3% | |
Deployment success | 99.3% | 96.1% to 100.0% | |
Non-TLR rate | 97.6% | 92.8% to 99.2% | |
Secondary safety endpoint | |||
In-stent restenosis | 8.5% | 4.8% to 15.0% | |
Mortality | 0.0% | – | |
Cerebrovascular event | Stroke and TIA | 7.2% | 3.9% to 12.9% |
Stroke | 1.4% | 0.4% to 5.6% | |
TIA | 5.7% | 2.9% to 11.1% | |
Cranial nerve palsy | 0.7% | 0.0% to 3.9% |
CI, confidence interval; MAE, major adverse event; TIA, transient ischemic attack; TLR, target lesion revascularization.