Dataset Information

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

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.

SUBMITTER: Song Y

PROVIDER: S-EPMC6992434 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Song Yunsun Y Sheen Jae Jon JJ Kim Joong Goo JG Lee Sang Hun SH Cho Su Hee SH Park Jung Cheol JC Choi Choong Gon CG Lee Deok Hee DH

Korean journal of radiology 20200201 2

<h4>Objective</h4>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.<h4>Materials and methods</h4>Between April 2016 and 2018, 50 patients (mean age, 56.5 years, 45 females [90%]) with 54 unruptured di ...[more]

PMID: 31997598

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Project description:BackgroundMore data is needed on the short- and medium-term efficacy and safety of the Willis covered stent in treating distal internal carotid artery (DICA) aneurysms and vertebral artery dissecting aneurysms (VADAs).MethodsRecords of all 42 patients with DICA aneurysms or VADAs treated with the Willis covered stents at our institute between July 2014 and January 2019 were retrospectively examined. The patients' demographic information, symptoms, diagnosis, treatment procedure, immediate and follow-up clinical and angiographic outcomes were extracted.Results46 Willis covered stents were successfully implanted in all of the 42 patients (total 43 aneurysms). Immediate complete aneurysm occlusion was achieved in 37 patients (38 aneurysms) (88.4%), and endoleak occurred to 5 patients (5 aneurysms) (11.6%). 2 patients died post-operatively from procedure-related complications, another one died from reasons unrelated to the procedure. Among the remaining 39 patients, non-lethal complications occurred in 4 patients including ptosis and diplopia of the right eye, intra-operative hemorrhage and carotid cavernous fistulas (CCF). Angiographic and clinical follow-ups (means ± standard deviation: 8.8 ± 5.3 months) were done for 32 patients (33 aneurysms). Complete occlusion was maintained in all of the 33 aneurysms. 2 of the 32 patients had significant though asymptomatic parent artery (PA) occlusion. No ischemic or hemorrhagic event occurred during the follow-up period. The modified Rankin Scale (mRS) score was 0 in 31 patients and 1 in the remaining 1 patient.ConclusionsThe Willis covered stent could be a safe and effective treatment for complex DICA aneurysms with excellent durability. In addition, the Willis covered stent treated all of the 3 cases of VADAs in the study with complete success without any complications, however, as the number of the VADA cases was small, more cases are needed to further confirm the efficacy and safety of the Willis covered stent in treating VADAs.

Project description:Background and purposeThe retreatment of recurrent intracranial vertebral artery dissecting aneurysms (VADAs) after stent assisted coiling (SAC) has not yet been studied. The purpose of this study was to evaluate the strategies and outcomes for retreatment of recurrent VADAs after SAC.MethodsBetween September 2009 and November 2013, six consecutive patients presenting with recurrent intracranial VADAs after SAC were enrolled in this study. They were all male with age ranging from 29 to 54 years (mean age, 46.2 years). The procedures of treatments and angiographic and clinical follow-up were reviewed retrospectively. Retreatment modalities were selected individually according to the characteristics of recurrence. The outcomes of retreatment were evaluated by angiographic and clinical follow-up.ResultsSix patients with recurrent intracranial VADAs after SAC were retreated, with second SAC in three patients, coil embolization, double overlapping stents placement and endovascular occlusion with aneurysm trapping in one patient, respectively. Immediate angiographic outcomes of retreatment were: complete occlusion in three patients, nearly complete occlusion in two patients, and contrast medium retention in dissecting aneurysm in one patient. All cases were technically successful. No complications related to endovascular procedures occurred. Angiographic follow-up was available in all five patients treated with second SAC or double overlapping stents, which was complete occlusion in four patients, obliteration of parent artery in one patient, showing no recurrence at 4-11 months (mean: 8.6 months). Clinical follow-up was performed in all six patients at 11-51 months after initial endovascular treatment and at 9-43 months after retreatment. The mRS of last clinical follow-up was excellent in five patients and mild disability in only one patient.ConclusionsEndovascular retreatment is feasible and effective for recurrent intracranial VADAs after SAC. Individualized strategies of retreatment should be enacted according to the characteristics and reasons for the recurrence.

Dataset Information

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

Publications

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

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