Clinical Trials in Italy / NCT04999423
Active, not recruiting
Observational
LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
NCT04999423 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Intracranial Aneurysm
Investigational drug(s) / intervention(s)
LVIS EVO and HydroCoil Embolic System
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
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 |
Other trials for the same condition
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.
View NCT04999423 on ClinicalTrials.gov ↗ ← All trials in Italy