Observational studyJournal of neurointerventional surgery2020
Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms.
Observational study in Journal of neurointerventional surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022Pooled it
- Multiple overlapping stent-assisted coiling improves efficacy and safety of treatment for complex intracranial aneurysms: a randomized trial.Biomedical engineering online · 2021Trial
- Five-Year Efficacy and Safety of the FRED Flow-Diverting Stent for Intracranial Aneurysms: Results From a Prospective Cohort.Stroke (Hoboken, N.J.) · 2026Article
- Usefulness of silent magnetic resonance angiography for intracranial aneurysms treated with a flow re-direction endoluminal device.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study.Scientific reports · 2025Observational
- Antiplatelet Therapy in Endovascular Treatment of Cerebral Aneurysms.Journal of neuroendovascular therapy · 2025Review
- Predicting the O'Kelly-Marotta scale score after flow-diverter stent placement using silent MRA.Japanese journal of radiology · 2024Article
- Endovascular Treatment of Cerebrovascular Lesions Using Nickel- or Nitinol-Containing Devices in Patients with Nickel Allergies.AJNR. American journal of neuroradiology · 2023Article
- Flow Diverter Treatment Using a Flow Re-Direction Endoluminal Device for Unruptured Intracranial Vertebral Artery Dissecting Aneurysm: Single-Center Case Series and Technical Considerations.Neurointervention · 2023Article
- Difference in the cumulative incidence of aneurysmal occlusion by Flow Re-direction Endoluminal Device and Pipeline Embolization Device in the treatment of unruptured internal carotid artery aneurysms: a propensity score-matched cohort study.Neurosurgical review · 2023Article
- Flow Diverter Performance for the Treatment of Intracranial Aneurysms: An International Multicenter Comparative Study.Stroke (Hoboken, N.J.) · 2023Article
- Endovascular treatment of challenging aneurysms with FRED Jr flow diverter stents: a single-center experience.Japanese journal of radiology · 2023Article
- Long-term vascular events after subarachnoid hemorrhage.Journal of neurology · 2022Article
- Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial.Journal of neurointerventional surgery · 2022Article
- Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment.Neuroradiology · 2022Article
- Implantation of Large Diameter (5.5-6 mm) Derivo Embolization Devices for the Treatment of Cerebral Aneurysms.Clinical neuroradiology · 2022Article
- Localized kinking during deployment of a flow redirection lumen device (FRED) could be due to excessive pushing.Surgical neurology international · 2022Article
- Brazilian FRED Registry: A Prospective Multicenter Study for Brain Aneurysm Treatment-The BRED Study.AJNR. American journal of neuroradiology · 2021Observational
- Long-term clinical and angiographic follow-up results of the dual-layer flow diverter device (FRED) for the treatment of intracranial aneurysms in a multicenter study.Neuroradiology · 2021Article
- Treatment of Intracranial Aneurysms Using the New Silk Vista Flow Diverter: Safety Outcomes at Short-Term Follow-Up.Frontiers in neurology · 2021Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo describe the efficacy and complications of treating cerebral aneurysms with the Flow Re-direction Endoluminal Device (FRED) and to identify predictors for aneurysm occlusion.
methodsA prospective observational registry including all consecutive aneurysms treated with FRED between December 2015 and July 2018 was designed in one therapeutic neuroangiography department. The primary endpoint for treatment efficacy was complete or near-complete occlusion (O'Kelly-Marotta (OKM) C-D), assessed by three-dimensional digital subtraction angiography. Major (all symptomatics) and minor complications were described and those with modified Rankin Scale scores 3-6 were considered clinically relevant. Univariate and multivariate analyses were performed to identify predictors of efficacy.
resultsA total of 185 aneurysms were analyzed in 150 patients (mean age 54.3±11.5 years). Mean follow-up was 18.99±11.32 months (range 0-43). Efficacy was evaluated in 156 (84.32%) cases: 132 (84.6%) had OKM C-D occlusion, 31/47 (66%) within the first year and 101/109 (92.7%) later on. Major complications were observed in 12 (6.5%) cases: three strokes (one transient ischemic accident, two minor strokes), six intra-stent thrombosis, and three with bleeding, but only one (0.5%) was clinically relevant. Minor complications (all asymptomatic) were observed in 10 (5.4%) cases: three shortening/repositioning of stent; two arterial dissection, two arterial occlusion, and three intra-stent stenosis. Independent predictors of occlusion were immediate OKM grade B-C-D (OR 4.01, 95% CI 1.51 to 10.62), single aneurysm (OR 3.29, 95% CI 1.05 to 10.32), and small size aneurysm (OR 4.74, 95% CI 1.57 to 14.30).
conclusionThe FRED stent fully complied with efficacy and safety requirements for treatment of intracranial aneurysms. Three predictors of aneurysm occlusion were identified.
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