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AzTrials

Aneurysm Cerebral (Unruptured)miniCANNCT07864389

Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms

A study testing 3D CEUS in people with Aneurysm Cerebral (Unruptured), run by Resolve Stroke at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aneurysm Cerebral (Unruptured)
What is being tested?
3D CEUS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
5 Oct 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (≥ 18 years of age)
  • Informed consent signed by the patient
  • Enrolled in a social security program or covered by an equivalent program
  • Presence of one or more unruptured, untreated intracranial aneurysms; typically bifurcation aneurysms, incidentally discovered, with a size of ≥ 3 mm; located at the base of the polygon of Willis in the Sylvian bifurcation, the anterior or posterior communicating artery, or the carotid or basilar terminal segments
  • Indications for diagnostic cerebral arteriography within a 6-month period following the discovery of one or more unruptured aneurysms

Who cannot join

  • Unusable temporal window
  • Withdrawal of Consent by the Patient
  • Cancellation of the appointment for a cerebral angiography
  • At the investigator's initiative, in the patient's best interest

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Lavaud, PhD contact

+33750529940

jonathan.lavaud@resolvestroke.com

France1 site, 1 recruiting

  • Nantes University Hospital

    Nantes, 44000

    Romain Bourcier, M.D.; Ph.D., +33(0)2 40 16 56 31, romain.bourcier@chu-nantes.fr

    Recruiting

Other trials in France

About this study

Official title: Proof of Concept Study to Evaluate the Feasibility of a Multimodal Approach Combining Angiography and 3D Ultrasound for the Hemodynamic Analysis of Unruptured, Untreated Intracranial Aneurysms

This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique.

Being tested
3D CEUS
Keywords
3DRA, Ultrasound, CEUS, aneurysm
Medical subject headings
Intracranial Aneurysm, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D CEUSDevice

    SYLVER is the investigational, non-invasive, class IIa ultrasound imaging system providing three-dimensional contrast-enhanced ultrasound (3D CEUS) imaging of the cerebral vasculature through the skull. Transcranial 3D CEUS acquisition is performed via the temporal acoustic window during the day-hospitalization for standard-of-care follow-up cerebral angiography, for a maximum of 30 minutes. Acquisitions are used to assess aneurysm presence, location and shape, intrasaccular flow organization (jet, recirculation, stagnation), filling completeness, and time-intensity curve and flow velocity parameters (time of arrival, time to peak, pulsatility index), which are compared with 3D rotational angiography.

Study groups in NCT07864389
Study groupRoleWhat they receive
SYLVER 3D CEUS and 3D Rotational AngiographyExperimentalParticipants undergo their standard-of-care diagnostic cerebral angiography, including 3D rotational angiography (3DRA), during a day hospitalization. During the same visit, a single research acquisition of 3D contrast-enhanced transcranial ultrasound is performed with the SYLVER imaging system (investigational, non-invasive, class IIa, not CE-marked) through the temporal acoustic window, after intravenous injection of an ultrasound contrast agent (SonoVue®). The research procedure lasts up to 30 minutes. Qualitative and quantitative hemodynamic parameters of the aneurysmal sac obtained with SYLVER are compared with 3DRA as the reference technique. Follow-up is limited to the day of the procedure.
Receives: Device: 3D CEUS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Qualitative agreement between SYLVER 3D CEUS and 3D Rotational Angiography for aneurysmal sac hemodynamic analysis

    Agreement between SYLVER 3D contrast-enhanced ultrasound and 3D rotational angiography (3DRA, reference technique) for qualitative parameters: aneurysm presence, location and shape; intrasaccular flow organization (jet, recirculation, stagnation); complete or partial sac filling. Agreement is expressed as observed percent agreement and, where relevant, kappa coefficient. Analysis is descriptive; no success threshold or statistical hypothesis is pre-specified.

    Measured: Day 1

  2. Quantitative agreement between SYLVER 3D CEUS and 3D Rotational Angiography for aneurysmal sac hemodynamic parameters

    Association and agreement between SYLVER 3D CEUS and 3DRA for quantitative hemodynamic parameters of the aneurysmal sac derived from the time-intensity curve (time of arrival, time to peak) and flow velocity (notably pulsatility index), analyzed in relation to intrasaccular flow organization. Association is assessed by Spearman correlation coefficient with 95% CI, and agreement by Bland-Altman limits of agreement. Analysis is descriptive.

    Measured: Day 1

Secondary outcomes (4)

  1. Feasibility of the multimodal angiography and 3D Ultrasound approach

    Number and percentage (with 95% CI) of participants with usable angiographic and ultrasound acquisitions, feasible co-registration of both modalities, and interpretable hemodynamic analysis of the aneurysmal sac.

    Measured: Day 1

  2. Healthcare staff time with SYLVER

    Time (minutes) spent by physicians, nursing assistants, radiographers and radiologists, measured with SYLVER.

    Measured: Day 1

  3. Associated costs with SYLVER

    Costs (euros) associated with the measured staff time, with SYLVER, to estimate the medico-economic impact of SYLVER use.

    Measured: Day 1

  4. Incidence of Adverse Events, Serious Adverse Events and Device Deficiencies

    Number and percentage of participants with adverse events (AEs) and serious adverse events (SAEs), and number of SYLVER device deficiencies, recorded in the eCRF.

    Measured: From inclusion to end of participation (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start5 Oct 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864389
Sponsor's protocol ID
2026-01
Other IDs
2026-A00918-43
Acronym
miniCAN
Status last verified
Sep 2026
First submitted
29 Sep 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wendl CM, Eiglsperger J, Schuierer G, Jung EM. Evaluating post-interventional occlusion grades of cerebral aneurysms with transcranial contrast-enhanced ultrasound (CEUS) using a matrix probe. Ultraschall Med. 2015 Apr;36(2):168-73. doi: 10.1055/s-0034-1398835. Epub 2015 Jan 21.

    PubMed 25607631

  • Perren F, Horn P, Kern R, Bueltmann E, Hennerici M, Meairs S. A rapid noninvasive method to visualize ruptured aneurysms in the emergency room: three-dimensional power Doppler imaging. J Neurosurg. 2004 Apr;100(4):619-22. doi: 10.3171/jns.2004.100.4.0619.

    PubMed 15070114

  • White PM, Wardlaw JM, Teasdale E, Sloss S, Cannon J, Easton V. Power transcranial Doppler ultrasound in the detection of intracranial aneurysms. Stroke. 2001 Jun;32(6):1291-7. doi: 10.1161/01.str.32.6.1291.

    PubMed 11387489

  • Newell DW, Winn HR. Transcranial Doppler in cerebral vasospasm. Neurosurg Clin N Am. 1990 Apr;1(2):319-28.

    PubMed 2136144

  • Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.

    PubMed 35211837

  • Yoon DY, Lim KJ, Choi CS, Cho BM, Oh SM, Chang SK. Detection and characterization of intracranial aneurysms with 16-channel multidetector row CT angiography: a prospective comparison of volume-rendered images and digital subtraction angiography. AJNR Am J Neuroradiol. 2007 Jan;28(1):60-7.

    PubMed 17213425

  • Sliwczynski A, Jewczak M, Dorobek M, Furlepa K, Golebiak I, Skibinska E, Sarzynska-Dlugosz I. An Analysis of the Incidence and Cost of Intracranial Aneurysm and Subarachnoid Haemorrhage Treatment between 2013 and 2021. Int J Environ Res Public Health. 2023 Feb 21;20(5):3828. doi: 10.3390/ijerph20053828.

    PubMed 36900834

Questions about this trial

What is this clinical trial studying?

A study testing 3D CEUS in people with Aneurysm Cerebral (Unruptured), run by Resolve Stroke at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Lavaud, PhD (+33750529940, jonathan.lavaud@resolvestroke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative agreement between SYLVER 3D CEUS and 3D Rotational Angiography for aneurysmal sac hemodynamic analysis (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07864389, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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