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Clinical Trials in the UK / NCT04572230
Active, not recruiting Observational

International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

NCT04572230 · tracked via the Priya Life Science UK tracker
Sponsor
Stryker Neurovascular
Phase
Observational
Started
2020-12-21
Last updated
2025-08-07

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

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)

Trial sites (32)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT04572230 on ClinicalTrials.gov ↗ ← All trials in the UK