Table 2

Endpoints in all patients

Primary endpointFrequency95% CI
Non-MAE rate98.6%94.4% to 99.6%
Secondary efficacy endpoint
Treatment success87.9%81.2% to 92.3%
Deployment success99.3%96.1% to 100.0%
Non-TLR rate97.6%92.8% to 99.2%
Secondary safety endpoint
In-stent restenosis8.5%4.8% to 15.0%
Mortality0.0%
Cerebrovascular eventStroke and TIA7.2%3.9% to 12.9%
Stroke1.4%0.4% to 5.6%
TIA5.7%2.9% to 11.1%
Cranial nerve palsy0.7%0.0% to 3.9%
  • CI, confidence interval; MAE, major adverse event; TIA, transient ischemic attack; TLR, target lesion revascularization.