Observational studyJournal of neurointerventional surgery2018
Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study.
Observational study in Journal of neurointerventional surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02921698 (Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment), which is not on this map. Cited by 35 papers, 6 of them syntheses 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.
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Who cites it
35 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Short to mid-term outcomes of flow re-direction endoluminal device X (FREDDiagnostic and interventional radiology (Ankara, Turkey) · 2026Pooled it
- Efficacy and safety of surpass evolve flow diverters: A systematic review and meta-analysis.Clinical neurology and neurosurgery · 2025Pooled 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
- Treatment of Unruptured Distal Anterior Circulation Aneurysms with Flow-Diverter Stents: A Meta-Analysis.AJNR. American journal of neuroradiology · 2019Pooled it
- Flow-Diversion Treatment of Unruptured Saccular Anterior Communicating Artery Aneurysms: A Systematic Review and Meta-Analysis.AJNR. American journal of neuroradiology · 2019Pooled it
- Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.Journal of neurointerventional surgery · 2020Trial
- Flow Diversion for Anterior Communicating Artery Aneurysms: Systematic Review and Meta-Analysis.Stroke (Hoboken, N.J.) · 2026Article
- The value of non-contrast and contrast-enhanced time-of-flight magnetic resonance angiography in the follow-up assessment of cerebral aneurysms treated with flow diverter stents.Neuroradiology · 2026Article
- The use of FD-HPC in Ruptured and Unruptured Aneurysms, the Italian Dataset (RUAID): Preliminary results on feasibility and safety.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
- Radiopaque FeMnN-Mo composite drawn filled tubing wires for braided absorbable neurovascular devices.Bioactive materials · 2024Article
- Article
- A rescue treatment to release the twist of a flow re-direction endoluminal device.Surgical neurology international · 2024Article
- Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design.Journal of neurointerventional surgery · 2023Article
- Endovascular treatment of challenging aneurysms with FRED Jr flow diverter stents: a single-center experience.Japanese journal of radiology · 2023Article
- Single flow diverter to manage multiple intracranial aneurysms in a parent artery.Journal of the Chinese Medical Association : JCMA · 2023Article
- Surpass Evolve Flow Diverter for the Treatment of Intracranial Aneurysm: A Systematic Review.Brain sciences · 2022Review
- Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment.Neuroradiology · 2022Article
- Flow-diverter stent to manage intracranial aneurysms: A single center experience.Journal of the Chinese Medical Association : JCMA · 2022Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeFlow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The
methodsUnruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment.
resultsA total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (<10 mm) in 71 patients (68.9%). Treatment was successfully performed in 98/103 patients (95.1%). Thromboembolic (TE) complications occurred in 5/103 patients (4.9%), intraoperative rupture in 2/103 patients (1.9%), delayed aneurysm rupture in 1/103 patient (1.0%), and delayed hematoma occurred in 1/103 patient (1.0%). Six-months' mortality and morbidity rates were 1/102 (1.0%) and 2/102 (2.0%), respectively.
conclusionsAneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%). CLINICAL
trial registrationNCT02921698.
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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.