Intracranial AneurysmIMPACTNCT04572230
International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach
An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 32 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Endovascular treatment of intracranial aneurysms using a flow-diverting stent
- Type of treatment
- Medical device
- How many people
- 405 participants
- Where
- 32 sitesin 7 countries
- Study dates
- 21 Dec 2020to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
France19 sites
CHU Amiens
Amiens
CHRU Besançon
Besançon
CHU Pellegrin Bordeaux
Bordeaux
CHU Cavale Blanche Brest
Brest
CHU Clermont-Ferrand
Clermont-Ferrand
Henri Mondor Créteil
Créteil
CHU la Tronche Grenoble
La Tronche
CHU Lille
Lille
CHU Bron-Lyon
Lyon
CHU la Timone Marseille
Marseille
CHU Montpellier
Montpellier
CHU Nancy
Nancy
Hospital Fondation Rothschild - Paris
Paris
La Pitié Salpétrière
Paris
NEURI, Kremlin Bicêtre
Paris
CHU Rennes
Rennes
CHU Charles Nicolle Rouen
Rouen
CHU Saint Etienne
Saint-Etienne
CHU Bretonneau Tours
Tours
Italy4 sites
AO Careggi Hospital
Florence
Ospedale Policlinico San Martino
Genova
Grande Ospedale Metropolitano Niguarda
Milan
Fondazione Policlinico Universitario A. Gemelli
Rome
Finland2 sites
Helsinki University Hospital
Helsinki
Turku University Hospital
Turku
Germany2 sites
Universitatsklinikum Augsburg A.o.R
Augsburg
University Hospital Knappschaftskrankenhaus Bochum
Bochum
Switzerland2 sites
Inselspital Bern
Bern
University Hospital of Zurich
Zurich
United Kingdom2 sites
Queen Elizabeth Hospital
Birmingham
NHS Lothian
Edinburgh
About this study
Official title: IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Endovascular treatment of intracranial aneurysms using a flow-diverting stent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of intracranial aneurysms using a flow-diverting stentDevice
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 group | Role | What they receive |
|---|---|---|
| Evolve EU | Selected hospitals for participation Receives: Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent | |
| Evolve FR | All hospitals in France using the device Receives: Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
Secondary Performance Measures
Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation
Measured: Through 24 months
Secondary Safety Endpoints
Procedural and device related serious adverse events, Any key neurological event of interest
Measured: Through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start21 Dec 2020
- Primary completion24 Oct 2024
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zsolt Kulcsár, PhD., MD, Principal investigator, Universitätsspital Zürich, Klinik für NeuroradiologieJean-Christophe Gentric, PhD., MD, Principal investigator, CHU Cavale Blanche Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572230
- Sponsor's protocol ID
- CDM10001731
- Acronym
- IMPACT
- Status last verified
- Nov 2024
- First submitted
- 25 Sep 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach
- ClinicalTrials.gov ID
- NCT04572230
- Acronym / sponsor ID
- IMPACT / CDM10001731
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolve EU | – | Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stentSelected hospitals for participation |
| Evolve FR | – | Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stentAll hospitals in France using the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment of intracranial aneurysms using a flow-diverting stentThe 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. | Device | Evolve EU, Evolve FR |
Primary outcome
Primary Performance Measure
Time frame: 12 months
Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment
Primary Safety Endpoint
Time frame: 12 months
Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC)
2 secondary outcomes
Secondary Performance Measures
Time frame: Through 24 months
Secondary Safety Endpoints
Time frame: Through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsolt Kulcsár, PhD., MD principal investigator
Universitätsspital Zürich, Klinik für Neuroradiologie
Jean-Christophe Gentric, PhD., MD principal investigator
CHU Cavale Blanche Brest
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 32 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France, Italy, Finland, Germany, Switzerland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Measure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.