Clinical trial NCT04999423: LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
Official title: Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Keywords: aneurysm
endovascular
hydrocoil
stent assisted coiling
LVIS EVO
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-10
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of aneurysms with complete occlusion
timeFrame: 12 ± 6-month
Secondary outcomes:
measure: 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
timeFrame: 30 ± 6 months
measure: RROC shift between immediate post procedure and each follow-up visit
timeFrame: 30 ± 6 months
measure: Aneurysm occlusion stability between immediate post procedure and each follow-up visit
timeFrame: 30 ± 6 months
measure: Proportion of aneurysms with stent successful deployment at the target aneurysm neck
timeFrame: Day 0
measure: Percentage of HES coil length implanted in the target aneurysm
timeFrame: Day 0
measure: Proportion of aneurysms with complete stent apposition
timeFrame: Day 0
measure: Occurrence of in-stent stenosis or parent artery occlusion at each follow-up
timeFrame: 30 ± 6 months
measure: Occurrence of target aneurysm recanalization at each follow-up
timeFrame: 30 ± 6 months
measure: Occurrence of target aneurysm retreatment at each follow-up
timeFrame: 30 ± 6 months
measure: Major ipsilateral stroke or neurological death within 12 months and 30 months
timeFrame: 30 ± 6 months
measure: Proportion of patients with good functional clinical outcomes
timeFrame: 30 ± 6 months
measure: Occurrence of subarachnoid hemorrhage
timeFrame: 30 ± 6 months
measure: Occurrence of Aneurysm rupture
timeFrame: 30 ± 6 months
measure: Occurrence of device-related serious adverse events
timeFrame: 30 ± 6 months
measure: Occurrence of procedural complications
timeFrame: Day 0
measure: All-cause mortality rate
timeFrame: 30 ± 6 months
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Charleroi University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Paris
country: France
facility: Fondation Rothschild
city: Rouen
country: France
facility: Rouen University Hospital
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Messina
country: Italy
facility: Policlinico Martino Messina
city: Salerno
country: Italy
facility: Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Liverpool
country: United Kingdom
facility: Walton Centre
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
affiliation: Alfried Krupp Krankenhaus
name: Rene Chapot, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Infirmary of Edinburgh
name: Jonathan Downer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: