AneurysmNCT04380350
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
An observational study of Aneurysm and Intracranial Aneurysm, run by Stryker Neurovascular at 18 sites in 7 countries.
Trial summary
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm, Intracranial Aneurysm
- How many people
- 150 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 17 Dec 2020to 12 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with Trenza device
Who may be able to join
- Age is ≥18 and ≤80 years
- Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment (Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days).
- Aneurysm morphology is saccular
- Aneurysm size is between 6-12 mm
- Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm
- If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2.
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- Must be willing to comply with protocol required procedures and follow up
- Must be willing to sign and date an Ethics Committee approved written informed consent prior to initiation of any screening or study procedures
- Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures
Who cannot join
- Target aneurysm has been previously treated.
- Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm.
- Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm.
- Treatment with flow diverting stent implant is anticipated.
- A planned, staged procedure is anticipated.
- Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery.
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- Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage.
- Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable)
- Has a known coagulopathy or is on chronic anticoagulant therapy.
- Is pregnant or intends to become pregnant during the study or is breastfeeding.
- Is concurrently involved in another study that could affect outcomes of IA treatment.
- Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years.
- Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure.
- Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
France6 sites
Bordeaux Hopsital
Bordeaux
Brest Hospital
Brest
HCL Lyon
Lyon
Montpellier Hospital
Montpellier
APHP Bicêtre
Paris
Purpan Hospital
Toulouse
Germany3 sites
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum
Asklepios Hospital Hamburg St. Georg
Hamburg
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck
United Kingdom3 sites
Queen Elizabeth Hospital Birmingham
Birmingham
NHS Lothian
Edinburgh
Queen Elizabeth University Hospital
Glasgow
Finland2 sites
Helsinski University Hospital
Helsinki
Turun yliopistollinen keskussairaala
Turku
Spain2 sites
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitario 12 de octubre
Madrid
About this study
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Read the detailed description
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
- Conditions
- Aneurysm, Intracranial Aneurysm
- Medical subject headings
- Aneurysm, Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety primary outcome measure
The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC)
- With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and;
- With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Measured: 1 year (± 6 months)
Effectiveness primary outcome measure
The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met:
- 100% occlusion (Raymond Class I) demonstrated by angiographic measurement at 12 months (+6/-3 months) post-procedure, or
- Stable Raymond Class II demonstrated on 2 serial angiographic measurements obtained a minimum of 6 months (± 1 month) apart
Measured: 1 year (± 6 months)
Secondary outcomes (1)
Safety secondary outcome measure
The secondary safety endpoint of this study is any stroke event occurring through 12 months post-procedure where a stroke event is defined as:
- Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage [IPH], subarachnoid hemorrhage [SAH], subdural hemorrhage [SDH], epidural hemorrhage [EDH]) accompanied with radiological evidence.
Measured: 1 year (± 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start17 Dec 2020
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Cognard, Pr, Principal investigator, Hospital Purpan, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380350
- Sponsor's protocol ID
- CDM10001446
- Status last verified
- Jun 2026
- First submitted
- 5 May 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trenza Embolization Device for Intrasaccular Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT04380350
- Acronym / sponsor ID
- CDM10001446
- Conditions
- Aneurysm, Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 8 May 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.
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Detailed description
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Trenza device
Key inclusion criteria (9 listed)
- Age is ≥18 and ≤80 years
- Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment (Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days).
- Aneurysm morphology is saccular
- Aneurysm size is between 6-12 mm
- Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm
Key exclusion criteria (14 listed)
- Target aneurysm has been previously treated.
- Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm.
- Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm.
- Treatment with flow diverting stent implant is anticipated.
- A planned, staged procedure is anticipated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety primary outcome measure
Time frame: 1 year (± 6 months)
The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Effectiveness primary outcome measure
Time frame: 1 year (± 6 months)
The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met: * 100% occlusion (Raymond Class I) demonstrated by angiographic measurement at 12 months (+6/-3 months) post-procedure, or * Stable Raymond Class II demonstrated on 2 serial angiographic measurements obtained a minimum of 6 months (± 1 month) apart
1 secondary outcome
Safety secondary outcome measure
Time frame: 1 year (± 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
Christophe Cognard, Pr principal investigator
Hospital Purpan, Toulouse, France
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Intracranial Aneurysm, run by Stryker Neurovascular at 18 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Germany, United Kingdom, Finland, Spain 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety primary outcome measure (time frame: 1 year (± 6 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 4 Jun 2026.