Trial reportKorean journal of radiology2025
FloWise Flow Diverter for Treatment of Unruptured Wide-Neck Intracranial Aneurysms: A Prospective, Multicenter, Single-Arm, Open-Label, Pivotal Study.
Trial report in Korean journal of radiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Prediction of Distal Dural Ring Location in Internal Carotid Paraclinoid Aneurysms Using the Tuberculum Sellae-Anterior Clinoid Process Line.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
objectiveWe evaluated the safety and efficacy of a new flow diverter in the treatment of unruptured wide-neck aneurysms. MATERIALS AND
methodsPatients who had unruptured intracranial aneurysms with a neck diameter ≥4 mm or dome-to-neck ratio <2 and who met other eligibility criteria were enrolled from seven institutions. The patients were treated with a new flow diverter (FloWise; Taewoong Medical, Seoul, Korea) and followed at 1, 3, 6, and 12 months after treatment. The primary efficacy endpoint was the complete occlusion of the target aneurysm at 12 months. Safety endpoints included ipsilateral stroke (National Institutes of Health Stroke Scale score ≥5), newly developed neurological deficit (modified Rankin Scale score ≥3), death at 30 days, and ≥50% parent artery stenosis or occlusion at the 12-month follow-up. The superiority of FloWise over the predefined reference value (56.7%) was investigated using a one-sided binomial test with a statistical significance of
resultsSeventy patients (59.0 ± 9.9 years; male:female = 16:54) with 93 aneurysms (median diameter, 5.2 mm [range, 1.6-26.1 mm]; median neck diameter, 4.1 mm [range, 1.2-22.4 mm]) were included. Of these, 69 patients who completed the follow-up as planned constituted the efficacy analysis set. Complete aneurysm occlusion was achieved in 56 target aneurysms (81.2%; 95% confidence interval [CI], 69.9-89.6;
conclusionFloWise flow diverter is safe and effective for the treatment of unruptured wide-neck aneurysms.
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Registered trials
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