International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
IMPACT
IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
1 other identifier
observational
405
7 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedAugust 7, 2025
November 1, 2024
3.8 years
September 25, 2020
August 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 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 Outcomes (2)
Secondary Performance Measures
Through 24 months
Secondary Safety Endpoints
Through 24 months
Study Arms (2)
Evolve EU
Selected hospitals for participation
Evolve FR
All hospitals in France using the device
Interventions
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
Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).
You may qualify if:
- 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
You may not qualify if:
- 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
- Subject has a non-target aneurysm treated within 30 days prior to study enrollment
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zsolt Kulcsár, PhD., MD
Universitätsspital Zürich, Klinik für Neuroradiologie
- PRINCIPAL INVESTIGATOR
Jean-Christophe Gentric, PhD., MD
CHU Cavale Blanche Brest
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
October 1, 2020
Study Start
December 21, 2020
Primary Completion
October 24, 2024
Study Completion
August 1, 2025
Last Updated
August 7, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After completion of the 12-month primary endpoint report
- Access Criteria
- A final report will be completed describing the results of all pre-specified outcomes, including negative results. The Sponsor will ensure investigators and regulatory authorities will receive the information contained in the final report.
After completion of the 12-month primary endpoint report, and under the guidance of a physician lead publication committee, a multi-center abstract reporting the results will be prepared and may be presented at a major meeting(s). A multi-center publication may also be prepared for publication in a peer reviewed scientific journal.