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.
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.
Study Type
OBSERVATIONAL
Enrollment
405
The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.
Uniklinik Salzburg
Salzburg, Austria
Primary Performance Measure
Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment
Time frame: 12 months
Primary Safety Endpoint
Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC)
Time frame: 12 months
Secondary Performance Measures
Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation
Time frame: Through 24 months
Secondary Safety Endpoints
Procedural and device related serious adverse events, Any key neurological event of interest
Time frame: Through 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 22 more locations