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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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIS EVO and HydroCoil Embolic System | Device | Stent assisted Coiling |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of aneurysms with complete occlusion | based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA) | 12 ± 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Raymond Roy Classification and Modified Raymond-Roy Classification evaluated by an independent Core laboratory | 30 ± 6 months |
| RROC shift between immediate post procedure and each follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Rene Chapot, Prof. | Alfried Krupp Krankenhaus | Principal Investigator |
| Jonathan Downer, Dr. | Royal Infirmary of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleroi University Hospital | Charleroi | Belgium | ||||
| Brest University Hospital |
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based on Raymond Roy Classification evaluated by an independent Core laboratory |
| 30 ± 6 months |
| Aneurysm occlusion stability between immediate post procedure and each follow-up visit | stable, improved, or worsened evaluated by an independent Core laboratory | 30 ± 6 months |
| Proportion of aneurysms with stent successful deployment at the target aneurysm neck | evaluated by an independent Core laboratory | Day 0 |
| Percentage of HES coil length implanted in the target aneurysm | HES coil length on the total coil length used | Day 0 |
| Proportion of aneurysms with complete stent apposition | evaluated by an independent Core laboratory | Day 0 |
| Occurrence of in-stent stenosis or parent artery occlusion at each follow-up | evaluated by an independent Core laboratory | 30 ± 6 months |
| Occurrence of target aneurysm recanalization at each follow-up | Aneurysm occlusion deterioration evaluated by an independent Core laboratory | 30 ± 6 months |
| Occurrence of target aneurysm retreatment at each follow-up | Retreatment or planned retreatment | 30 ± 6 months |
| Major ipsilateral stroke or neurological death within 12 months and 30 months | assessed by an independent clinical event committee | 30 ± 6 months |
| Proportion of patients with good functional clinical outcomes | 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) | 30 ± 6 months |
| Occurrence of subarachnoid hemorrhage | assessed by an independent clinical event committee | 30 ± 6 months |
| Occurrence of Aneurysm rupture | assessed by an independent clinical event committee | 30 ± 6 months |
| Occurrence of device-related serious adverse events | assessed by an independent clinical event committee | 30 ± 6 months |
| Occurrence of procedural complications | assessed by an independent clinical event committee | Day 0 |
| All-cause mortality rate | assessed by an independent clinical event committee | 30 ± 6 months |
| 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 |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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