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
Study Type
OBSERVATIONAL
Enrollment
206
Stent assisted Coiling
Charleroi University Hospital
Charleroi, Belgium
Brest University Hospital
Brest, France
Proportion of aneurysms with complete occlusion
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA)
Time frame: 12 ± 6-month
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
Time frame: 30 ± 6 months
RROC shift between immediate post procedure and each follow-up visit
based on Raymond Roy Classification evaluated by an independent Core laboratory
Time frame: 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
Time frame: 30 ± 6 months
Proportion of aneurysms with stent successful deployment at the target aneurysm neck
evaluated by an independent Core laboratory
Time frame: Day 0
Percentage of HES coil length implanted in the target aneurysm
HES coil length on the total coil length used
Time frame: Day 0
Proportion of aneurysms with complete stent apposition
evaluated by an independent Core laboratory
Time frame: Day 0
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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
...and 9 more locations
Occurrence of in-stent stenosis or parent artery occlusion at each follow-up
evaluated by an independent Core laboratory
Time frame: 30 ± 6 months
Occurrence of target aneurysm recanalization at each follow-up
Aneurysm occlusion deterioration evaluated by an independent Core laboratory
Time frame: 30 ± 6 months
Occurrence of target aneurysm retreatment at each follow-up
Retreatment or planned retreatment
Time frame: 30 ± 6 months
Major ipsilateral stroke or neurological death within 12 months and 30 months
assessed by an independent clinical event committee
Time frame: 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)
Time frame: 30 ± 6 months
Occurrence of subarachnoid hemorrhage
assessed by an independent clinical event committee
Time frame: 30 ± 6 months
Occurrence of Aneurysm rupture
assessed by an independent clinical event committee
Time frame: 30 ± 6 months
Occurrence of device-related serious adverse events
assessed by an independent clinical event committee
Time frame: 30 ± 6 months
Occurrence of procedural complications
assessed by an independent clinical event committee
Time frame: Day 0
All-cause mortality rate
assessed by an independent clinical event committee
Time frame: 30 ± 6 months