LVIS EVO and HydroCoil Embolic System: Stent assisted Coiling
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
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)
Trial sites (19)
Facility
City
Region
Status
Charleroi University Hospital
Charleroi
Belgium
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
France
Universitätsklinikum Augsburg
Augsburg
Germany
Universitätsklinikum Knappschaftskrankenhaus
Bochum
Germany
Alfried Krupp Krankenhaus
Essen
Germany
Universitätsklinikum Münster
Münster
Germany
Azienda Ospedaliera Cannizzaro
Catania
Italy
Policlinico Martino Messina
Messina
Italy
Ospedali riuniti San Giovanni di Dio e Ruggi d'Aragona
Salerno
Italy
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
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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