Evidence map›Paper›PMID 39984615›Full record

Observational studyScientific reports2025

The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study.

Maciej Jaworski, Remigiusz Krysiak, Jarosław Żyłkowski, Mariusz Banach, Miłosz Zbroszczyk, Kamila Smulska, Sławomir Bereza, Katarzyna Lubkowska, Ewa Horoch-Łyszczarek, Paweł Brzegowy and 12 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

22 authors.

Maciej JaworskiII Department of Clinical Radiology Warszawa, Medical University of Warsaw, Warszawa, PL, Poland.
Remigiusz KrysiakII Department of Clinical Radiology Warszawa, Medical University of Warsaw, Warszawa, PL, Poland. remik.krysiak@gmail.com.
Jarosław ŻyłkowskiII Department of Clinical Radiology Warszawa, Medical University of Warsaw, Warszawa, PL, Poland.
Mariusz BanachDepartment of Neurosurgery Kraków, Saint Raphael Hospital, Kraków, PL, Poland.
Miłosz ZbroszczykDepartment of Radiodiagnostic and Interventional Radiology Katowice, Medical University of Silesia, Katowice, PL, Poland.
Kamila SmulskaDepartment of Radiodiagnostic and Interventional Radiology Katowice, Medical University of Silesia, Katowice, PL, Poland.
Sławomir BerezaDepartement of Interventional Neuroradiology Wrocław, Lower Silesian Specialistic Marciniak Memorial Hospital, Wrocław, PL, Poland.
Katarzyna LubkowskaDepartement of Interventional Neuroradiology Wrocław, Lower Silesian Specialistic Marciniak Memorial Hospital, Wrocław, PL, Poland.
Ewa Horoch-ŁyszczarekDepartement of Neurology Wrocław, Lower Silesian Specialistic Marciniak Memorial Hospital, Wrocław, PL, Poland.
Paweł BrzegowyRadiology Department Kraków, Medical College Jagiellonian University, Kraków, PL, Poland.
Tadeusz PopielaRadiology Department Kraków, Medical College Jagiellonian University, Kraków, PL, Poland.
Wojciech PoncyljuszDepartment of Diagnostic Imaging and Interventional Radiology Szczecin, Pomeranian Medical University in Szczecin, Szczecin, PL, Poland.
Michał ZawadzkiDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional Neuroradiology, Warszawa, PL, Poland.
Błażej NowakDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional Neuroradiology, Warszawa, PL, Poland.
Mateusz PinkiewiczDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional Neuroradiology, Warszawa, PL, Poland.
Jarosław WrzyszczDepartment of Neurosurgery Grudziądz, Regional Specialist Hospital named after Dr. WI. Bieganski, Grudziądz, PL, Poland.
Katarzyna MokrzyckaDepartment of Neurosurgery Grudziądz, Regional Specialist Hospital named after Dr. WI. Bieganski, Grudziądz, PL, Poland.
Maciej SzajnerDepartment of Interventional Neuroradiology Lublin, Medical University of Lublin, Lublin, PL, Poland.
Christophe CognardDiagnostic and Therapeutic Neuroradiology Place du Dr Baylac Toulouse , Hôpital Purpan , Toulouse, FR, France.
Edoardo BoccardiNeuroradiology Milano, Ospedale Niguarda Ca'Granda, Milano, IT, Italy.
Raphael BlancDepartement of Interventional Neuroradiology Paris Fondation de Rothschild , Paris, FR, France.
Michel PiotinDepartement of Interventional Neuroradiology Paris Fondation de Rothschild , Paris, FR, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This Polish multicenter study aims to evaluate the effectiveness and safety of the Flow Direction Endoluminal Device (FRED) in treating selected unruptured intracranial aneurysms. The FRED Poland Study was an observational, multicenter, prospective study conducted in 8 Polish investigational sites. Imaging results were independently assessed by a Corelab and adverse events were adjudicated by a Clinical Events Committee (CEC). Clinical results up to 24 months and anatomical results at 6-, 12- and 24-months post-treatment were reported. A total of 86 patients with 89 target aneurysms were enrolled between January 2016 and September 2017. Most aneurysms were located on the anterior circulation (93.2%, 83/89 aneurysms) with the majority (64.0%, 57/89) being small (< 10 mm) in size. Treatment was successfully performed in 86 out of 89 cases (96.6%). The permanent neurological morbidity rate was 3.6%, and the neurological mortality rate was 2.4%. Imaging follow-up at 6 months showed complete occlusion of the aneurysm in 64.9% of cases, increasing to 79.5% at 12 months and 85.5% at 24 months. This study offers a comprehensive overview of the flow diversion treatment approach, demonstrating that the FRED device is effective and safe for use in intracranial aneurysm treatment. These results align with existing literature, reaffirming the device reliability and suitability for clinical use.

Indexed as

Endovascular ProceduresIntracranial AneurysmAdultAgedFemaleHumansMaleMiddle AgedPolandProspective StudiesTreatment Outcome

Identifiers

PMID39984615
PMCPMC11845520

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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.