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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: LVIS EVO and HydroCoil Embolic System

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

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium
    • Charleroi University Hospital
• France
  • Brest, France
    • Brest University Hospital
  • Limoges, France
    • Limoges University Hospital
  • Lyon, France
    • Lyon University Hospital
  • Marseille, France
    • Marseille University hospital
  • Paris, France
    • Fondation Rothschild
  • Rouen, France
    • Rouen University Hospital
• Germany
  • Augsburg, Germany
    • Universitätsklinikum Augsburg
  • Bochum, Germany
    • Universitätsklinikum Knappschaftskrankenhaus
  • Essen, Germany
    • Alfried Krupp Krankenhaus
  • Münster, Germany
    • Universitatsklinikum Munster
• Italy
  • Catania, Italy
    • Azienda Ospedaliera Cannizzaro
  • Messina, Italy
    • Policlinico Martino Messina
  • Salerno, Italy
    • Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona
• United Kingdom
  • Edinburgh, United Kingdom
    • Royal Infirmary of Edinburgh
  • Liverpool, United Kingdom
    • Walton Centre
  • London, United Kingdom
    • The Royal London Hospital
  • London, United Kingdom
    • Charing Cross Hospital
  • London, United Kingdom
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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)

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 ± 6 months
RROC shift between immediate post procedure and each follow-up visit	based on Raymond Roy Classification evaluated by an independent Core laboratory	30 ± 6 months
Aneurysm occlusion stability between immediate post procedure and each follow-up visit	stable, improved, or worsened evaluated by an independent Core laboratory	30 ± 6 months
Proportion of aneurysms with stent successful deployment at the target aneurysm neck	evaluated by an independent Core laboratory	Day 0
Percentage of HES coil length implanted in the target aneurysm	HES coil length on the total coil length used	Day 0
Proportion of aneurysms with complete stent apposition	evaluated by an independent Core laboratory	Day 0
Occurrence of in-stent stenosis or parent artery occlusion at each follow-up	evaluated by an independent Core laboratory	30 ± 6 months
Occurrence of target aneurysm recanalization at each follow-up	Aneurysm occlusion deterioration evaluated by an independent Core laboratory	30 ± 6 months
Occurrence of target aneurysm retreatment at each follow-up	Retreatment or planned retreatment	30 ± 6 months
Major ipsilateral stroke or neurological death within 12 months and 30 months	assessed by an independent clinical event committee	30 ± 6 months
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)	30 ± 6 months
Occurrence of subarachnoid hemorrhage	assessed by an independent clinical event committee	30 ± 6 months
Occurrence of Aneurysm rupture	assessed by an independent clinical event committee	30 ± 6 months
Occurrence of device-related serious adverse events	assessed by an independent clinical event committee	30 ± 6 months
Occurrence of procedural complications	assessed by an independent clinical event committee	Day 0
All-cause mortality rate	assessed by an independent clinical event committee	30 ± 6 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Rene Chapot, Prof., Alfried Krupp Krankenhaus; Principal Investigator: Jonathan Downer, Dr., Royal Infirmary of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: aneurysm; endovascular; hydrocoil; stent assisted coiling; LVIS EVO
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: SEALANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No