Evidence map›Paper›PMID 39837601›Full record

ArticleJournal of neurointerventional surgery2025

Retrospective multicenter analysis of the Trenza Embolization Device for endovascular therapy of intracranial aneurysms: initial results and short-term follow-up.

Marcel N Wolf, Luca Valvassori, Andrea Gioppo, Riitta Rautio, Jan Hoeltje, Peter Schramm, Ivan Jovanovic, David Ozretic, Jan-Hendrik Buhk, Luca Allegretti and 3 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of neurointerventional surgery, 2025. 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. Article
  2. Review
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

13 authors.

Marcel N WolfDepartment of Neuroradiology, University Medical Center of Johannes Gutenberg University Mainz, Mainz, Germany Marcel.Wolf@unimedizin-mainz.de.ORCID http://orcid.org/0009-0009-5128-5556
Luca ValvassoriDepartment of Neuroradiology, ASST Santi Paolo E Carlo, Milan, Italy.
Andrea GioppoDepartment of Neuroradiology, ASST Santi Paolo E Carlo, Milan, Italy.
Riitta RautioDepartment of Interventional Radiology, Turku University Hospital (TYKS), Turku, Finland.ORCID http://orcid.org/0000-0001-8385-0622
Jan HoeltjeDepartment of Neuroradiology, University Medical Center Schleswig-Holstein, Lübeck, Germany.
Peter SchrammDepartment of Neuroradiology, University Medical Center Schleswig-Holstein, Lübeck, Germany.
Ivan JovanovicDepartment of Diagnostic and Interventional Neuroradiology, University Hospital Centre Zagreb, Zagreb, Croatia.
David OzreticDepartment of Diagnostic and Interventional Neuroradiology, University Hospital Centre Zagreb, Zagreb, Croatia.
Jan-Hendrik BuhkNeuroradiology, Asklepios Hospital St. Georg, Hamburg, Germany.
Luca AllegrettiDepartment of Neuroradiology, Santa Corona Hospital, Pietra Ligure, Italy.
Marielle ErnstDepartment of Diagnostic and Interventional Neuroradiology, University Medical Center Göttingen, Göttingen, Germany.ORCID http://orcid.org/0000-0003-2870-4109
Marc A BrockmannDepartment of Neuroradiology, University Medical Center of Johannes Gutenberg University Mainz, Mainz, Germany.
Ahmed E OthmanDepartment of Neuroradiology, University Medical Center of Johannes Gutenberg University Mainz, Mainz, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntrasaccular devices are increasingly used in endovascular therapy of intracranial aneurysms, in particular wide-necked and ruptured aneurysms. The Trenza Embolization Device (TED) is an innovative intrasaccular device for medium- to large-sized aneurysms. Currently, literature about the TED is scarce.

methodsIn eight participating European centers, 25 aneurysms (3 ruptured) in 25 patients (18 females, mean age 62.4 years) treated with the TED outside the currently recruiting prospective, post-market, multicenter study were included in this retrospective, multicenter analysis. Primary endpoints for clinical safety were the absence of stroke and death. Primary endpoint for technical success was implantation of TED without necessity of adjunct stenting. Primary and secondary endpoints for efficacy were adequate angiographic occlusion according to the Modified Raymond-Roy Classification (MRRC) immediately after the procedure and at first follow-up (FU).

resultsStent-assistance was required in two cases. Thus primary endpoint for technical success was reached in 23/25 (92%) cases. With one symptomatic thrombotic event, primary safety endpoint was reached in 24/25 (96%) cases. At the end of the procedure, complete occlusion (MRRC I) was achieved in 12/25 (48%), and a small residual neck (MRRC II) remained in 13/25 (52%) cases. In 19 cases FU (mean 6 months) was available, showing adequate occlusion in 17/19 (89.5%) cases (MRRC I in 8/19 and stable MRRC II in 9/19 cases) and relevant reperfusion MRRC IIIa with indication to retreatment in 2/19 (10.5%) cases.

conclusionsThe results of this first retrospective, multicenter experience with the TED appear promising. Further prospective, multicenter studies with larger patient cohorts, as well as long-term FU, are required.

Indexed as

Embolization, TherapeuticEndovascular ProceduresIntracranial AneurysmAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedRetrospective StudiesStentsTreatment OutcomeAneurysmAngiographyFlow Diverter

Identifiers

PMID39837601
PMCPMC12703241

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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.