Table 3

Primary effectiveness endpoint through 1 year post-procedure by aneurysm location (FAS population with observed data)

Primary effectiveness endpoint†Rate*95% CI
All aneurysms143/200 (71.7%)(65.0% to 77.7%)
Intracranial ICA (C2-C7 including terminus)109/144 (75.7%)(67.9% to 82.4%)
Non-intracranial ICA28/45 (62.2%)(46.5% to 76.2%)
 C11/2 (50.0%)(1.3% to 98.7%)
 Vertebral8/13 (61.5%)(31.6% to 86.1%)
 MCA7/13 (53.8%)(25.1% to 80.8%)
 ACA6/8 (75.0%)(34.9% to 96.8%)
 AComm6/9 (66.7%)(29.9% to 92.5%)
  • Data are % (n/N). FAS population is n=200; representing the number of patients with follow-up information.

  • *Numerator represents subjects who had complete aneurysm occlusion without significant parent artery stenosis (>=50%) at 1-year post-procedure or without re-treatment of the target aneurysm. Occlusion and stenosis are based on core laboratory data, and retreatment is based on site reported data.

  • †The primary effectiveness endpoint was assessed using the last adjudicated image at any time starting from day 141, unless the last image is a CTA and there is a DSA within 90 days prior to the CTA, in which case the DSA was used, or the last image is an MRA and there was a DSA or CTA within 90 days prior to the MRA, in which case the DSA or CTA was used. If both existed, DSA was preferred over CTA.

  • ACA, anterior cerebral artery; AComm, anterior communicating artery; ICA, internal carotid artery; MCA, middle cerebral artery.