Abstract
OBJECTIVE: The Alpha stent (CGBio), a new intracranial stent featuring a re-sheathable mesh design with improved wall apposition at the curved segment, was clinically evaluated. We report the 6-month follow-up results from a prospective, single-center study in which the stent was used for coiling of wide-necked distal internal carotid artery (ICA) aneurysms. MATERIALS AND METHODS: Between April 2016 and 2018, 50 patients (mean age, 56.5 years, 45 females [90%]) with 54 unruptured distal ICA aneurysms (average diameter: 5.6 ± 1.7 mm) were enrolled. The primary endpoint for effectiveness was successful coil embolization with the Alpha stent, and subsequent complete or near-complete occlusion at the 6-month magnetic resonance angiography assessment. The primary safety endpoint was the absence of serious adverse events (SAEs) up to 6 months from the procedure. RESULTS: The primary effectiveness endpoint was observed in 94.4% (51/54) aneurysms. In one patient with technical failure, the stent could not be deployed because of parent artery tortuosity; therefore, a different type of stent was used. Of the 53 aneurysms treated with the Alpha stent, complete occlusion was achieved in 64.1% (34/53) cases, and near-complete occlusion was achieved in 32.0% (17/53) cases by the 6-month follow-up. Two cases (3.7%) required retreatment because of major recurrence. In 4% (2/50) patients, SAEs, i.e., retinal artery thromboembolism and corona radiata lacunar infarction, were reported after the procedure. CONCLUSION: For endovascular treatment of unruptured, wide-necked, distal ICA aneurysms, coil embolization using the newly developed Alpha stent showed excellent procedural and mid-term clinical follow-up results in terms of effectiveness and safety.