Clinical trial NCT04572230: International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
Official title: IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Primary Performance Measure
timeFrame: 12 months
measure: Primary Safety Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Performance Measures
timeFrame: Through 24 months
measure: Secondary Safety Endpoints
timeFrame: Through 24 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Uniklinik Salzburg
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Amiens
country: France
facility: CHU Amiens
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: CHU Pellegrin Bordeaux
city: Brest
country: France
facility: CHU Cavale Blanche Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: Henri Mondor Créteil
city: La Tronche
country: France
facility: CHU la Tronche Grenoble
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: CHU Bron-Lyon
city: Marseille
country: France
facility: CHU la Timone Marseille
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: Hospital Fondation Rothschild - Paris
city: Paris
country: France
facility: La Pitié Salpétrière
city: Paris
country: France
facility: NEURI, Kremlin Bicêtre
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Charles Nicolle Rouen
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Tours
country: France
facility: CHU Bretonneau Tours
city: Augsburg
country: Germany
facility: Universitatsklinikum Augsburg A.o.R
city: Bochum
country: Germany
facility: University Hospital Knappschaftskrankenhaus Bochum
city: Florence
country: Italy
facility: AO Careggi Hospital
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Milan
country: Italy
facility: Grande Ospedale Metropolitano Niguarda
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: Universitätsspital Zürich, Klinik für Neuroradiologie
name: Zsolt Kulcsár, PhD., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Cavale Blanche Brest
name: Jean-Christophe Gentric, PhD., MD
role: PRINCIPAL_INVESTIGATOR
References: