LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT04999423
- Lead Sponsor
- Microvention-Terumo, Inc.
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 206
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Percentage of HES coil length implanted in the target aneurysm Day 0 HES coil length on the total coil length used
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
Occurrence of target aneurysm recanalization at each follow-up 30 ± 6 months Aneurysm occlusion deterioration evaluated by an independent Core laboratory
Occurrence of procedural complications Day 0 assessed by an independent clinical event committee
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
Occurrence of in-stent stenosis or parent artery occlusion at each follow-up 30 ± 6 months evaluated by an independent Core laboratory
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)
All-cause mortality rate 30 ± 6 months assessed by an independent clinical event committee
Proportion of aneurysms with stent successful deployment at the target aneurysm neck Day 0 evaluated by an independent Core laboratory
Proportion of aneurysms with complete stent apposition Day 0 evaluated by an independent Core laboratory
Occurrence of target aneurysm retreatment at each follow-up 30 ± 6 months Retreatment or planned retreatment
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
Trial Locations
- Locations (19)
Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Lyon University Hospital
🇫🇷Lyon, France
Rouen University Hospital
🇫🇷Rouen, France
Brest University Hospital
🇫🇷Brest, France
Walton Centre
🇬🇧Liverpool, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
Policlinico Martino Messina
🇮🇹Messina, Italy
Marseille University Hospital
🇫🇷Marseille, France
Azienda Ospedaliera Cannizzaro
🇮🇹Catania, Italy
Fondation Rothschild
🇫🇷Paris, France
Universitätsklinikum Knappschaftskrankenhaus
🇩🇪Bochum, Germany
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Limoges University Hospital
🇫🇷Limoges, France
Alfried Krupp Krankenhaus
🇩🇪Essen, Germany
King's College Hospital
🇬🇧London, United Kingdom
Charleroi University Hospital
🇧🇪Charleroi, Belgium
Charing Cross Hospital
🇬🇧London, United Kingdom