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

NCT04999423 | Active Not Recruiting

• 1 other identifier: SEALANT
• Study Type: observational
• Target: 206
• Locations: 5 countries
• Sites: 19

Brief 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

Conditions

Intracranial Aneurysm

Keywords

aneurysm; endovascular; hydrocoil; stent assisted coiling; LVIS EVO

Outcome Measures

Primary Outcomes (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)

  12 ± 6-month

Secondary Outcomes (16)

• 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

  30 ± 6 months

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

  30 ± 6 months

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

  30 ± 6 months

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

  Day 0

• Percentage of HES coil length implanted in the target aneurysm

  Day 0

Interventions

LVIS EVO and HydroCoil Embolic System DEVICE

Stent assisted Coiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (19)

Charleroi University Hospital

Charleroi, Belgium

Location

Brest University Hospital

Brest, France

Location

Limoges University Hospital

Limoges, France

Location

Lyon University Hospital

Lyon, France

Location

Marseille University Hospital

Marseille, France

Location

Fondation Rothschild

Paris, France

Location

Rouen University Hospital

Rouen, France

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Universitätsklinikum Knappschaftskrankenhaus

Bochum, Germany

Location

Alfried Krupp Krankenhaus

Essen, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Azienda Ospedaliera Cannizzaro

Catania, Italy

Location

Policlinico Martino Messina

Messina, Italy

Location

Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Walton Centre

Liverpool, United Kingdom

Location

Charing Cross Hospital

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

The Royal London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rene Chapot, Prof.

  Alfried Krupp Krankenhaus

  PRINCIPAL INVESTIGATOR

• Jonathan Downer, Dr.

  Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 10, 2021
• Study Start: January 14, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); FR (6); DE (4); BE (1); IT (3)