Evidence map›Paper›PMID 34413065›Full record

Observational studyAJNR. American journal of neuroradiology2021

Brazilian FRED Registry: A Prospective Multicenter Study for Brain Aneurysm Treatment-The BRED Study.

L B Manzato, R B Santos, P M M Filho, G Miotto, A M Bastos, J R Vanzin

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in AJNR. American journal of neuroradiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

L B ManzatoFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil lbmanzato@hotmail.com.ORCID 0000-0002-4291-3831
R B SantosFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.ORCID 0000-0003-2473-6613
P M M FilhoFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.ORCID 0000-0003-1375-9203
G MiottoFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.ORCID 0000-0002-3675-5718
A M BastosFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.ORCID 0000-0003-2760-1941
J R VanzinFrom the Department of Interventional Neuroradiology (L.B.M., P.M.M.F., G.M., J.R.V.), Neurology and Neurosurgery Service, Clinicas Hospital of Passo Fundo, Passo Fundo, Rio Grande do Sul, Brazil.ORCID 0000-0002-5100-5624

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThe development of flow diverters has changed the endovascular approach to intracranial aneurysms. On the basis of good results, the indications for flow diverters have expanded to include aneurysms of different shapes, locations, and sizes. The objective of the study was to report on the performance of the Flow Re-Direction Endoluminal Device (FRED) in intracranial aneurysm treatment at early and medium-term follow-up. MATERIALS AND

methodsThis single-arm, multicentric, prospective, observational study assessed aneurysm treatment with the FRED. The primary outcome was complete aneurysm occlusion at 6 and 12 months, and the secondary outcome was to evaluate the safety of the FRED with respect to stroke and death rates.

resultsBetween June 2016 and August 2018, a total of 100 consecutive patients with 131 aneurysms were treated in 107 procedures. Total occlusion rates were 91% and 95% at 6 and 12 months. There was 1 death, and the total final morbidity rate was 1.8%. The complication rate was 4.6%.

conclusionsAs reported previously, the FRED has proved to be a safe and effective tool, with high occlusion rates. The design of the stent makes it more difficult to perform balloon angioplasty compared with similar devices. A branch arising from the aneurysm sac was found to be a predictor of nonocclusion at 12 months, though larger series are needed to estimate the magnitude of the association.

Indexed as

Embolization, TherapeuticEndovascular ProceduresIntracranial AneurysmFollow-Up StudiesHumansProspective StudiesRegistriesStentsTreatment Outcome

Identifiers

PMID34413065
PMCPMC8562762

What OpenQuestion holds

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Registered trials

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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.