Korean J Radiol.  2020 Feb;21(2):228-235. 10.3348/kjr.2019.0188.

Alpha Stent for Coiling of Unruptured, Wide-Necked, Distal Internal Carotid Artery Aneurysms: Safety and Effectiveness at 6 Months

Affiliations
  • 1Department of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. dhlee@amc.seoul.kr
  • 2Department of Neurosurgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
  • 3Department of Neurology, Jeju National University Hospital, Jeju, Korea.
  • 4Department of Neurology, Korea University Ansan Hospital, Ansan, Korea.
  • 5Department of Neurosurgery, Gangneung Asan Hospital, Gangneung, Korea.

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.

Keyword

Adults; Aneurysms; Stents; Stent grafts; Coil embolisation
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