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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04572230
Other study ID # CDM10001731
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date June 30, 2025

Study information

Verified date October 2023
Source Stryker Neurovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date June 30, 2025
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Uniklinik Salzburg Salzburg
Finland Helsinki University Hospital Helsinki
Finland Turku University Hospital Turku
France 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-Étienne
France CHU Bretonneau Tours Tours
Germany Universitatsklinikum Augsburg A.o.R Augsburg
Germany University Hospital Knappschaftskrankenhaus Bochum Bochum
Italy AO Careggi Hospital Florence
Italy Ospedale Policlinico San Martino Genova
Italy Grande Ospedale Metropolitano Niguarda Milan
Italy Fondazione Policlinico Universitario A. Gemelli Rome
Switzerland Inselspital Bern Bern
Switzerland University Hospital of Zurich Zürich
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom The Royal Infirmary of Edinburgh Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

Austria,  Finland,  France,  Germany,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Primary Primary Safety Endpoint Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC) 12 months
Secondary Secondary Performance Measures Target aneurysm recanalization, Parent artery stenosis = 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation Through 24 months
Secondary Secondary Safety Endpoints Procedural and device related serious adverse events, Any key neurological event of interest Through 24 months
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