Evidence map›Paper›PMID 35360928›Full record

ArticleStroke2022

Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA).

Manuel Requena, Marc Ribo, Joaquin Zamarro, Pedro Vega, Jordi Blasco, Eva María González, María Del Mar Freijo, Jose Carlos Mendez Cendón, María Ángeles de Miquel, David Hernández and 8 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Stroke, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04095767 (Prospective, Single-Arm, Multi-center Study to Assess the Safety and Performance of the ANA Catheter System, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
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.

NCT04095767 naterminatednot on this map

Prospective, Single-Arm, Multi-center Study to Assess the Safety and Performance of the ANA Catheter System, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke

TypeinterventionalSponsorAnaconda Biomed S.L.Ran2019 to 2021Enrolled74ConditionsStroke, IschemicArmsNeurothrombectomy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 5 countries.

Manuel RequenaStroke Unit, Department of Neurology (M. Requena, M. Ribo), Hospital Universitari Vall d'Hebron, Barcelona, Spain.ORCID 0000-0002-5671-6484
Marc RiboStroke Unit, Department of Neurology (M. Requena, M. Ribo), Hospital Universitari Vall d'Hebron, Barcelona, Spain.ORCID 0000-0001-9242-043X
Joaquin ZamarroInterventional Neuroradiology, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain (J.Z.).ORCID 0000-0002-0504-6775
Pedro VegaInterventional Neuroradiology, Department of Radiology, Hospital Universitario Central de Asturias, Spain (P.V.).ORCID 0000-0002-7446-4540
Jordi BlascoDepartment of Radiology, Hospital Clínic, Barcelona, Spain (J.B.).ORCID 0000-0002-7703-4642
Eva María GonzálezInterventional Neuroradiology, Department of Radiology (E.M.G.), Hospital Cruces, Bilbao, Spain.ORCID 0000-0002-2749-7155
María Del Mar FreijoDepartment of Neurology (M.D.M.F.), Hospital Cruces, Bilbao, Spain.ORCID 0000-0002-4293-8705
Jose Carlos Mendez CendónDepartment of Radiology, Ramón y Cajal University Hospital, Madrid, Spain (J.C.M.C.).
María Ángeles de MiquelDepartment of Radiology, Hospital Universitari de Bellvitge, Barcelona, Spain (M.A.d.M.).ORCID 0000-0003-4730-9913
David HernándezInterventional Neuroradiology Section, Department of Radiology (M. Requena, D.H., A.T.), Hospital Universitari Vall d'Hebron, Barcelona, Spain.ORCID 0000-0001-6715-4547
Manuel MoreuNeurointerventional Radiology, Department of Radiology, Hospital Clínico San Carlos, Madrid, Spain (M.M.).ORCID 0000-0002-9001-0661
Sebastià RemolloNeurointerventional Radiology Unit, Department of Neurosciences, Hospital Germans Trias i Pujol, Badalona, Spain (S.R.).ORCID 0000-0002-8514-5529
Sonia SánchezAnaconda Biomed, Barcelona, St Cugat del Valles, Spain (S.S.).ORCID 0000-0001-6345-7444
David S LiebeskindNeurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California (D.S.L.).ORCID 0000-0002-5109-8736
Tommy AnderssonInterventional Neuroradiology Section, Department of Radiology (M. Requena, D.H., A.T.), Hospital Universitari Vall d'Hebron, Barcelona, Spain.ORCID 0000-0001-8202-7829
Christophe CognardHôpital Purpan, Diagnostic and Therapeutic Neuroradiology, Toulouse, France (C.C.).ORCID 0000-0003-4287-2627
Raul NogueiraDepartment of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital and Department of Neurology, Atlanta, GA (R.N.).ORCID 0000-0003-4532-153X
Alejandro TomaselloORCID 0000-0002-6736-1535
Vall d'Hebron Hospital Universitari · ESHospital de Cruces · ESBellvitge University Hospital · ESGrady Memorial Hospital · USHôpital Purpan · FRHospital Clínic de Barcelona · ESHospital Clínico San Carlos · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitario Central de Asturias · ESHospital Universitario Virgen de la Arrixaca · ESInstituto Cajal · ESKarolinska University Hospital · SEMedian SCP (Spain) · ESUniversity of California System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system.

methodsSOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices).

resultsAfter enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10-19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%-91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c-3) of 60% (95% CI, 48.4%-71.1%; 43/72 patients). After noninferiority was confirmed (

conclusionsIn this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04095767.

Indexed as

Brain IschemiaIschemic StrokeStrokeAgedCathetersCerebral InfarctionFemaleHumansMaleProspective StudiesStentsThrombectomyTreatment Outcomecathetersischemic strokereperfusionstentsthrombectomy

Identifiers

PMID35360928
PMCPMC9232250
OpenAlexW4220934333

What OpenQuestion holds

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LicenceCC BY
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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.