Observational studyJournal of neurointerventional surgery2019
SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results.
Observational study in Journal of neurointerventional surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 79 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial
Who cites it
79 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis.Journal of neurointerventional surgery · 2023Pooled 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
- FloWise Flow Diverter for Treatment of Unruptured Wide-Neck Intracranial Aneurysms: A Prospective, Multicenter, Single-Arm, Open-Label, Pivotal Study.Korean journal of radiology · 2025Trial
- Staged coiling and flow diversion for a ruptured persistent primitive hypoglossal artery aneurysm: illustrative case.Journal of neurosurgery. Case lessons · 2026Article
- Application of machine learning algorithms to predict and assess factors related to internal carotid siphon aneurysm occlusion treated with flow diversion.Neuroradiology · 2026Article
- Flow Diversion vs. Coiling for Large and Giant Intracranial Aneurysms: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2026Review
- Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026Review
- Factors Associated with Aneurysm Occlusion after Flow Diverter Treatment.Journal of neuroendovascular therapy · 2026Review
- PANTHER: Prasugrel-based aneurysm treatment with non-identical telescoping with flow diversion with hydrophilic polymer coating for endovascular reconstruction in acute subarachnoid hemorrhage.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Circumferential Aneurysm Wall Enhancement Predicts Recanalization After Stent-Assisted Coiling in Small Unruptured Intracranial Aneurysms.Brain and behavior · 2025Article
- Flow diversion with hydrophilic polymer coating with prasugrel as single antiplatelet therapy in the treatment of acutely ruptured intracranial aneurysms: a multicenter case series, complication and occlusion rates.Journal of neurointerventional surgery · 2025Article
- Treatment of Intracranial Aneurysms with the FRED X Flow Diverter Stent: Mid-term Angiographic and Safety Results.Clinical neuroradiology · 2025Article
- Prediction and SHAP Analysis Integrating Morphological and Hemodynamic Parameters for Unruptured Intracranial Aneurysm Occlusion After Flow Diverter Treatment.CNS neuroscience & therapeutics · 2025Article
- Determining flow stasis zones in the intracranial aneurysms and the relation between these zones and aneurysms' aspect ratios after flow diversions.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Treatment outcomes and effectiveness of FRED for fusiform vertebral artery aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Use of Cobalt-Chromium 64 Wires Surpass Evolve for the Treatment of Remnant Intracranial Aneurysms: A Subanalysis From the SEASE International Registry.Stroke (Hoboken, N.J.) · 2025Article
- Effect of the Effective Metal Surface Area of Two Different Flow Diverter Stents on the Stagnation Region Formation Inside the Aneurysm Sac.Asian journal of neurosurgery · 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
- Multicenter analysis of the incidence of in-stent stenosis following the deployment of flow-redirection endoluminal device in the treatment of intracranial aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Use of p48 flow diverters with hydrophilic polymer coating under prasugrel single antiplatelet therapy for intracranial aneurysms arising from small-caliber vessels (≤ 2 mm): case series, complication, and occlusion rates.Frontiers in neurology · 2025Article
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeFlow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.
methodsPatients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.
resultsThirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).
conclusionsSAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)). CLINICAL
trial registrationUnique identifier: NCT02921698; Results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.