Primary effectiveness endpoint† | Rate* | 95% CI |
All aneurysms | 143/200 (71.7%) | (65.0% to 77.7%) |
Intracranial ICA (C2-C7 including terminus) | 109/144 (75.7%) | (67.9% to 82.4%) |
Non-intracranial ICA | 28/45 (62.2%) | (46.5% to 76.2%) |
C1 | 1/2 (50.0%) | (1.3% to 98.7%) |
Vertebral | 8/13 (61.5%) | (31.6% to 86.1%) |
MCA | 7/13 (53.8%) | (25.1% to 80.8%) |
ACA | 6/8 (75.0%) | (34.9% to 96.8%) |
AComm | 6/9 (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.