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AzTrials

Intracranial AneurysmSEALANTNCT04999423

LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment

An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 19 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
LVIS EVO and HydroCoil Embolic System
Type of treatment
Medical device
How many people
206 participants
Where
19 sitesin 5 countries
Study dates
14 Jan 2022to 1 Dec 2026
Phase
Observational
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

Study population: Patients presenting with an unruptured or ruptured (> 30 days since occurrence) intracranial aneurysm eligible for endovascular treatment using LVIS™ Evo™ and HydroCoil® Embolic System (HES)

Who may be able to join

  • IC 1. Patient whose age is 18 years old or above;
  • IC 2. Patient (or legal representative, where applicable) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed;
  • IC 3. Patient eligible for the treatment with LVIS™ Evo™ and HydroCoil® Embolic System (HES);
  • IC 4. Patient whose target aneurysm is unruptured or ruptured (> 30 days since occurrence);
  • IC 5. Patient whose target aneurysm size is less than or equal to 12 mm;
  • IC 6. Patient willing to comply with all planned follow-ups and evaluations.

Who cannot join

  • EC 1 Patient who has suffered an intracerebral hemorrhage within 30 days prior to the procedure;
  • EC 2. Patient whose target aneurysm is a fusiform aneurysm;
  • EC 3. Patient whose target aneurysm has previously been treated with a stent;
  • EC 4. Patient whose target aneurysm is partially thrombosed;
  • EC 5. Patient whose target aneurysm requires Y stenting;
  • EC 6. Patient whose target aneurysm is associated with an arteriovenous malformation (cAVM), or any other lesion that could lead to hemorrhagic complications;
Show all 13Show fewer
  • EC 7. Patient who has more than one aneurysm to be treated during the same procedure, (except in case of an adjacent aneurysm that could be treated with the same stent);
  • EC 8. Patient for whom the treatment with another stent than LVIS™ Evo™ or in addition to LVIS™ Evo™ is planned;
  • EC 9. Patient with a planned treatment of other aneurysm in the same vascular territory within 12 months;
  • EC 10. Patient who has a known allergy to contrast agents (that cannot be adequately premedicated) and/or to the study device or procedure-required concomitant medications or procedures (e.g. contraindication to antiplatelet and/or anticoagulants, allergy to Nickel-titanium or contraindication to MRI/MRA or angiography);
  • EC 11. Patient who has one of the following (as assessed prior to the index procedure): Other serious medical illness (e.g., cancer or any severe or fatal comorbidity) with estimated life expectancy of less than the study duration, OR Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
  • EC 12. Patient who is participating or intends to participate in another study that changes the site practice (interventional) within the study time period;
  • EC 13. Pregnant or breastfeeding woman.

Trial locations and contacts

19 sites in 5 countries.

19 sites in 5 countries

France6 sites

  • Brest University Hospital

    Brest

  • Limoges University Hospital

    Limoges

  • Lyon University Hospital

    Lyon

  • Marseille University Hospital

    Marseille

  • Fondation Rothschild

    Paris

  • Rouen University Hospital

    Rouen

Other trials in France

United Kingdom5 sites

  • Royal Infirmary of Edinburgh

    Edinburgh

  • Walton Centre

    Liverpool

  • Charing Cross Hospital

    London

  • King's College Hospital

    London

  • The Royal London Hospital

    London

Other trials in United Kingdom

Germany4 sites

  • Universitätsklinikum Augsburg

    Augsburg

  • Universitätsklinikum Knappschaftskrankenhaus

    Bochum

  • Alfried Krupp Krankenhaus

    Essen

  • Universitätsklinikum Münster

    Münster

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliera Cannizzaro

    Catania

  • Policlinico Martino Messina

    Messina

  • Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona

    Salerno

Other trials in Italy

Belgium1 site

  • Charleroi University Hospital

    Charleroi

Other trials in Belgium

About this study

Official title: Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment

This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure

Read the detailed description

Patient treatment and follow-up will be performed as per standard of care. The study will evaluate the proportion of aneurysms with complete occlusion based on Raymond-Roy occlusion classification (RROC) at 12 ± 6-months, as well as other effectiveness and safety endpoints such as the occurence of stent stenosis or parent artery occlusion, the occurence of retreatment and recanalization, the rate of major ipsilateral stroke or neurological death, the proportion of patients with good functional clinical outcome, the occurence of SAH, aneurysm rupture, procedural complications, serious adverse events...

Sample size: 200 patients

Being tested
LVIS EVO and HydroCoil Embolic System
Keywords
aneurysm, endovascular, hydrocoil, stent assisted coiling, LVIS EVO
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.

  • LVIS EVO and HydroCoil Embolic SystemDevice

    Stent assisted Coiling

What is being measured

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

  1. Proportion of aneurysms with complete occlusion

    based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA)

    Measured: 12 ± 6-month

Secondary outcomes (16)

  1. Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III, and Modified Raymond-Roy Classification at immediate post procedure and each follow-up visits

    Raymond Roy Classification and Modified Raymond-Roy Classification evaluated by an independent Core laboratory

    Measured: 30 ± 6 months

  2. RROC shift between immediate post procedure and each follow-up visit

    based on Raymond Roy Classification evaluated by an independent Core laboratory

    Measured: 30 ± 6 months

  3. Aneurysm occlusion stability between immediate post procedure and each follow-up visit

    stable, improved, or worsened evaluated by an independent Core laboratory

    Measured: 30 ± 6 months

  4. Proportion of aneurysms with stent successful deployment at the target aneurysm neck

    evaluated by an independent Core laboratory

    Measured: Day 0

  5. Percentage of HES coil length implanted in the target aneurysm

    HES coil length on the total coil length used

    Measured: Day 0

  6. Proportion of aneurysms with complete stent apposition

    evaluated by an independent Core laboratory

    Measured: Day 0

  7. Occurrence of in-stent stenosis or parent artery occlusion at each follow-up

    evaluated by an independent Core laboratory

    Measured: 30 ± 6 months

  8. Occurrence of target aneurysm recanalization at each follow-up

    Aneurysm occlusion deterioration evaluated by an independent Core laboratory

    Measured: 30 ± 6 months

  9. Occurrence of target aneurysm retreatment at each follow-up

    Retreatment or planned retreatment

    Measured: 30 ± 6 months

  10. Major ipsilateral stroke or neurological death within 12 months and 30 months

    assessed by an independent clinical event committee

    Measured: 30 ± 6 months

  11. Proportion of patients with good functional clinical outcomes

    a good functional outcome is defined by an mRS between 0 and 2, or an mRS equal to baseline if it was > 2 at baseline, with mRS is the modified Rankin Scale (a neurological score from 0: no deficit to 6: death)

    Measured: 30 ± 6 months

  12. Occurrence of subarachnoid hemorrhage

    assessed by an independent clinical event committee

    Measured: 30 ± 6 months

  13. Occurrence of Aneurysm rupture

    assessed by an independent clinical event committee

    Measured: 30 ± 6 months

  14. Occurrence of device-related serious adverse events

    assessed by an independent clinical event committee

    Measured: 30 ± 6 months

  15. Occurrence of procedural complications

    assessed by an independent clinical event committee

    Measured: Day 0

  16. All-cause mortality rate

    assessed by an independent clinical event committee

    Measured: 30 ± 6 months

Timeline

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

  1. First posted10 Aug 2021
  2. Study start14 Jan 2022
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Dec 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04999423
Sponsor's protocol ID
SEALANT
Acronym
SEALANT
Status last verified
Jan 2025
First submitted
28 Jul 2021
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Downer J, Eker OF, Riva R, Berlis A, Pitrone A, Stracke P, Tancredi I, Mounayer C, Papagiannaki C, Chandran A, Gentric JC, Brunel H, Piotin M, Kandasamy N, Fischer S, Makalanda L, Romano DG, Tahon F, Piano M, Boccardi E, Chapot R. Stent-assisted coiling with LVIS Evo and HydroCoil embolic system: 1-year results of the SEALANT study. J Neurointerv Surg. 2026 Jul 23:jnis-2026-025179. doi: 10.1136/jnis-2026-025179. Online ahead of print.

    PubMed 42493243

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 19 sites in 5 countries.

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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, United Kingdom, Germany, Italy, Belgium. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of aneurysms with complete occlusion (time frame: 12 ± 6-month). 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 NCT04999423, which also lists 1 linked publication.

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 7 Jan 2025.

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