Evidence map›Paper›PMID 37055159›Full record

ArticleAJNR. American journal of neuroradiology2023

Dual-Layer Detector Cone-Beam CT Angiography for Stroke Assessment: First-in-Human Results (the Next Generation X-ray Imaging System Trial).

F Ståhl, H Almqvist, J Kolloch, Å Aspelin, V Gontu, E Hummel, M van Vlimmeren, M Simon, A Thran, Å Holmberg and 3 more

Erratum issued Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in AJNR. American journal of neuroradiology, 2023. 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 NCT04571099 (Next Generation X-ray Imaging System), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04571099 completednot on this map

Next Generation X-ray Imaging System

TypeobservationalSponsorPhilips Clinical & Medical Affairs GlobalRan2020 to 2021Enrolled28ConditionsStroke, Acute
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

F StåhlFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.) Fredrik.stahl@regionstockholm.se.ORCID 0000-0002-9690-0286
H AlmqvistFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0002-0363-1284
J KollochFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0003-1403-5039
Å AspelinFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0002-2307-4155
V GontuFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0002-5941-7412
E HummelImage Guided Therapy (E.H., M.v.V.), Phillips Healthcare, Best, the Netherlands.ORCID 0000-0002-5005-6008
M van VlimmerenImage Guided Therapy (E.H., M.v.V.), Phillips Healthcare, Best, the Netherlands.ORCID 0000-0003-1870-0921
M SimonPhilips Research Hamburg (M. Simon, A.T.), Hamburg, Germany.ORCID 0000-0001-6895-9961
A ThranPhilips Research Hamburg (M. Simon, A.T.), Hamburg, Germany.ORCID 0000-0002-4007-4421
Å HolmbergFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0001-7472-5854
M V MazyaNeurology (M.V.M.), Karolinska University Hospital, Stockholm, Sweden.ORCID 0000-0002-0377-3506
M SödermanFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0003-3642-3702
A F DelgadoFrom the Departments of Neuroradiology (F.S., H.A., J.K., Å.A., V.G., Å.H., M. Söderman, A.F.D.).ORCID 0000-0003-4389-5089

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeIn patients with stroke, IV cone-beam CTA in the angiography suite could be an alternative to CTA to shorten the door-to-thrombectomy time. However, image quality in cone-beam CTA is typically limited by artifacts. This study evaluated a prototype dual-layer detector cone-beam CT angiography versus CTA in patients with stroke. MATERIALS AND

methodsA prospective, single-center trial enrolled consecutive patients with ischemic or hemorrhagic stroke on initial CT. Intracranial arterial segment vessel conspicuity and artifact presence were evaluated on dual-layer cone-beam CTA 70-keV virtual monoenergetic images and CTA. Eleven predetermined vessel segments were matched for every patient. Twelve patients were necessary to show noninferiority to CTA. Noninferiority was determined by the exact binomial test; the 1-sided lower performance boundary was prospectively set to 80% (98.75% CI).

resultsTwenty-one patients had matched image sets (mean age, 72 years). After excluding examinations with movement or contrast media injection issues, all readers individually considered dual-layer cone-beam CT angiography noninferior to CTA (CI boundary, 93%, 84%, 80%, respectively) when evaluating arteries relevant in candidates for intracranial thrombectomy. Artifacts were more prevalent compared with CTA. The majority assessment rated each individual segment except M1 as having noninferior conspicuity compared with CTA.

conclusionsIn a single-center stroke setting, dual-layer detector cone-beam CTA virtual monoenergetic images are noninferior to CTA under certain conditions. Notably, the prototype is hampered by a long scan time and is not capable of contrast media bolus tracking. After excluding examinations with such scan issues, readers considered dual-layer detector cone-beam CTA noninferior to CTA, despite more artifacts.

Indexed as

Contrast MediaStrokeAgedAngiographyComputed Tomography AngiographyHumansProspective StudiesX-RaysContrast Media

Identifiers

PMID37055159
PMCPMC10171384

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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.