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

Intracranial Aneurysm Clinical Trial

— SEALANT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04999423
• Other study ID #: SEALANT
• Status: Active, not recruiting
• Start date: January 14, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• LVIS EVO and HydroCoil Embolic System
Stent assisted Coiling

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Proportion of aneurysms with stent successful deployment at the target aneurysm neck	evaluated by an independent Core laboratory	Day 0
Secondary	Percentage of HES coil length implanted in the target aneurysm	HES coil length on the total coil length used	Day 0
Secondary	Proportion of aneurysms with complete stent apposition	evaluated by an independent Core laboratory	Day 0
Secondary	Occurrence of in-stent stenosis or parent artery occlusion at each follow-up	evaluated by an independent Core laboratory	30 ± 6 months
Secondary	Occurrence of target aneurysm recanalization at each follow-up	Aneurysm occlusion deterioration evaluated by an independent Core laboratory	30 ± 6 months
Secondary	Occurrence of target aneurysm retreatment at each follow-up	Retreatment or planned retreatment	30 ± 6 months
Secondary	Major ipsilateral stroke or neurological death within 12 months and 30 months	assessed by an independent clinical event committee	30 ± 6 months
Secondary	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
Secondary	Occurrence of subarachnoid hemorrhage	assessed by an independent clinical event committee	30 ± 6 months
Secondary	Occurrence of Aneurysm rupture	assessed by an independent clinical event committee	30 ± 6 months
Secondary	Occurrence of device-related serious adverse events	assessed by an independent clinical event committee	30 ± 6 months
Secondary	Occurrence of procedural complications	assessed by an independent clinical event committee	Day 0
Secondary	All-cause mortality rate	assessed by an independent clinical event committee	30 ± 6 months