Endovascular treatment of intracranial aneurysms using a flow-diverting stent
Endovascular treatment of intracranial aneurysms using a flow-diverting stent: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria (Evolve EU and Evolve FR):
* Subject has an intracranial aneurysm that can be treated with one of the proposed devices
* Subject age is ≥ 18 years
* Subject or subject's legally authorized representative (LAR) has signed written informed consent
* Subject is willing to comply with scheduled visits and examinations per institutional standard of care
Exclusion Criteria for (Evolve EU and Evolve FR):
* Subject is pregnant or plans to become pregnant her study participation\*.
* Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device study.
* Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow-up, e.g.).
* Subject has a non-target aneurysm treated within 30 days prior to study enrollment.
* Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study.
* Subject target aneurysm is a ruptured intracranial aneurysm (unless ruptured at least 21 days prior the day of the index procedure)
* Subject has a target aneurysm other than saccular or fusiform intracranial aneurysms; e.g.: vertebrobasilar dolichoectasia (VBD)
* The parent vessel size does not fall within the indicated range defined by IFU
* Antiplatelet and/or anticoagulation therapy (e.g., aspirin and clopidogrel) is contraindicated for the subject
* Subject has not received dual anti-platelet agents prior to the procedure or equivalent in accordance with standard medical practice
* Subject has an active bacterial or viral infection
* The angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
* Severe intracranial vessel tortuosity or stenosis; and/or
* Intracranial vasospasm not responsive to medical therapy
Additional Key Exclusion Criteria (Evolve EU only):
* Subject has a non-target aneurysm treated within 30 days prior to study enrollment
* Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study
* Subject has a modified Rankin Score (mRS) ≥3 at pre-procedure examination
* Subject has undergone previous stent assisted coiling or flow diverter treatment of a parent artery aneurysm near the location of the target aneurysm
Primary outcome measure(s)
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)
Trial sites (32)
Facility
City
Region
Status
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
CHU Rennes
Rennes
France
CHU Charles Nicolle Rouen
Rouen
France
CHU Saint Etienne
Saint-Etienne
France
CHU Bretonneau Tours
Tours
France
Universitatsklinikum Augsburg A.o.R
Augsburg
Germany
University Hospital Knappschaftskrankenhaus Bochum
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.