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

Intracranial Aneurysm Clinical Trial

— IMPACT  

Official title:

IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04572230
• Other study ID #: CDM10001731
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

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