International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
- Conditions
- Intracranial Aneurysm
- Interventions
- Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent
- Registration Number
- NCT04572230
- Lead Sponsor
- Stryker Neurovascular
- Brief Summary
IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
- Detailed Description
IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used.
In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 405
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Evolve EU Endovascular treatment of intracranial aneurysms using a flow-diverting stent Selected hospitals for participation Evolve FR Endovascular treatment of intracranial aneurysms using a flow-diverting stent All hospitals in France using the device
- Primary Outcome Measures
Name Time Method Primary Performance Measure 12 months Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment
Primary Safety Endpoint 12 months Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC)
- Secondary Outcome Measures
Name Time Method Secondary Performance Measures Through 24 months Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation
Secondary Safety Endpoints Through 24 months Procedural and device related serious adverse events, Any key neurological event of interest
Trial Locations
- Locations (32)
CHU Rennes
🇫🇷Rennes, France
CHU Charles Nicolle Rouen
🇫🇷Rouen, France
CHU Saint Etienne
🇫🇷Saint-Étienne, France
CHU Bretonneau Tours
🇫🇷Tours, France
Universitatsklinikum Augsburg A.o.R
🇩🇪Augsburg, Germany
University Hospital Knappschaftskrankenhaus Bochum
🇩🇪Bochum, Germany
AO Careggi Hospital
🇮🇹Florence, Italy
NHS Lothian
🇬🇧Edinburgh, United Kingdom
Uniklinik Salzburg
🇦🇹Salzburg, Austria
Helsinki University Hospital
🇫🇮Helsinki, Finland
Turku University Hospital
🇫🇮Turku, Finland
CHU Amiens
🇫🇷Amiens, France
CHRU Besançon
🇫🇷Besançon, France
CHU Pellegrin Bordeaux
🇫🇷Bordeaux, France
CHU Cavale Blanche Brest
🇫🇷Brest, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Henri Mondor Créteil
🇫🇷Créteil, France
CHU la Tronche Grenoble
🇫🇷La Tronche, France
CHU Lille
🇫🇷Lille, France
CHU Bron-Lyon
🇫🇷Lyon, France
CHU la Timone Marseille
🇫🇷Marseille, France
CHU Montpellier
🇫🇷Montpellier, France
CHU Nancy
🇫🇷Nancy, France
Hospital Fondation Rothschild - Paris
🇫🇷Paris, France
La Pitié Salpétrière
🇫🇷Paris, France
NEURI, Kremlin Bicêtre
🇫🇷Paris, France
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
Fondazione Policlinico Universitario A. Gemelli
🇮🇹Rome, Italy
Inselspital Bern
🇨🇭Bern, Switzerland
University Hospital of Zurich
🇨🇭Zürich, Switzerland
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom