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

Sponsor

Microvention-Terumo, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04999423

Collaborator

(none)

200

Enrollment

Locations

58.5

Anticipated Duration (Months)

10.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 14, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Outcome Measures

Primary Outcome Measures

Proportion of aneurysms with complete occlusion [12 ± 6-month]
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Charleroi University Hospital	Charleroi	Belgium
2	Brest University Hospital	Brest	France
3	Limoges University Hospital	Limoges	France
4	Lyon University Hospital	Lyon	France
5	Marseille University Hospital	Marseille	France
6	Fondation Rothschild	Paris	France
7	Rouen University Hospital	Rouen	France
8	Universitätsklinikum Augsburg	Augsburg	Germany
9	Universitätsklinikum Knappschaftskrankenhaus	Bochum	Germany
10	Alfried Krupp Krankenhaus	Essen	Germany
11	Universitätsklinikum Münster	Münster	Germany
12	Azienda Ospedaliera Cannizzaro	Catania	Italy
13	Policlinico Martino Messina	Messina	Italy
14	Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona	Salerno	Italy
15	Royal Infirmary of Edinburgh	Edinburgh	United Kingdom
16	Walton Centre	Liverpool	United Kingdom
17	Charing Cross Hospital	London	United Kingdom
18	King's College Hospital	London	United Kingdom
19	The Royal London Hospital	London	United Kingdom