International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
NCT ID: NCT04572230
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
405 participants
OBSERVATIONAL
2020-12-21
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Evolve EU
Selected hospitals for participation
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.
Evolve FR
All hospitals in France using the device
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Zsolt Kulcsár, PhD., MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Zürich, Klinik für Neuroradiologie
Jean-Christophe Gentric, PhD., MD
Role: PRINCIPAL_INVESTIGATOR
CHU Cavale Blanche Brest
Locations
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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
Bochum, , Germany
AO Careggi Hospital
Florence, , Italy
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
Zurich, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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CDM10001731
Identifier Type: -
Identifier Source: org_study_id
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