Saccular and Fusiform AneurysmsTRUSTNCT07474935
Targeting Real World Usage In Stroke Treatment
An observational study of Saccular and Fusiform Aneurysms and Pseudoaneurysm, run by Phenox GmbH at 13 sites in 5 countries.
Trial summary
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection
- What is being tested?
- Aneurysm Treatment with a Neurovascular Flow Diverter, Dissection Treatment with a Neurovascular Flow Diverter and Perforation Treatment with a Neurovascular Flow Diverter
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 29 Jan 2026to Jan 2041
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The registry population comprising of patients suffering from cranial diseases as per indication of target registry devices (intracranial aneurysms, pseudo-aneurysms, neurovascular abnormalities, dissections, perforations, neurovascular abnormalities, and other indication), is deemed representative of the target population in terms of characteristics and standard care.
Who may be able to join
- Subject treated or intended to be treated with at least one target registry device during the procedure (i.e., at least one attempt of introduction into the vasculature of the subject),
- Non-opposition to data collection or informed consent provided by the subject or legal representative as per country-specific legislation.
Who cannot join
- Participation in an interventional study modifying standard care management for all relevant indications,
Trial locations and contacts
13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 5 countries
Germany5 sites, 5 recruiting
- Not yet recruiting
Helios Klinikum Erfurt
Erfurt, 99089
Joachim KLISCH, Prof., joachim.klisch@helios-gesundheit.de
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Maxim BESTER, PD. Dr., m.bester@uke.de
- Not yet recruiting
University Hospital Heidelberg
Heidelberg, 69120
Markus MÖHLENBRUCH, Prof., markus.moehlenbruch@med.uni-heidelberg.de
- Not yet recruiting
LMU Klinikum
München, 81377
Thomas LIEBIG, Prof. Dr., Thomas.Liebig@med.uni-muenchen.de
- Not yet recruiting
Klinikum Nürnberg
Nuremberg, 90471
Markus HOLTMANNSPÖTTER, Dr., Markus.Holtmannspoetter@klinikum-nuernberg.de
Italy3 sites, 3 recruiting
- Not yet recruiting
Cannizzaro Hospital in Catania
Catania, 95126
Guglielmo PERO, Dr., Guglielmo.pero@gmail.com
Concetto CRISTAUDO, Prof.
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milan, 20162
Mariangela PIANO, Dr., mariangela.piano@ospedaleniguarda.it
- Not yet recruiting
Antonio Cardarelli Hospital- Naples
Naples, 80131
Mario MUTO, Prof.
Amedeo CERVO, Dr.
France2 sites, 2 recruiting
- Recruiting
CHU Brest - Hôpital de La Cavale Blanche
Brest, 29200
Jean-Christophe GENTRIC, Prof. Dr., +33 2 98 34 74 87, jean-christophe.gentric@chu-brest.fr
- Not yet recruiting
Pitié Salpêtrière Hospital
Paris, 75013
Frédéric CLARENÇON, Prof. Dr., frederic.clarencon@aphp.fr
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Universitätsspital Basel
Basel, 4031
Marios-Nikos PSYCHOGIOS, Prof., marios.psychogios@usb.ch
- Not yet recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9007
Victoria HELLSTERN, Dr., victoria.hellstern@h-och.ch
Slovakia1 site, 1 recruiting
- Recruiting
Univerzitná nemocnica L. Pasteura Košice
Košice, 040 11
Piotr PEDOWSKI, Dr., +42155640 4213, piotr.pedowski@unlp.sk
About this study
Official title: TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.
The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.
- Conditions
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation, Bifurcation Aneurysms, Stenosis
- Being tested
- Aneurysm Treatment with a Neurovascular Flow Diverter, Dissection Treatment with a Neurovascular Flow Diverter, Perforation Treatment with a Neurovascular Flow Diverter, Arteriovenous Fistula treatment with a Neurovascular Flow Diverter, Aneurysm Treatment with Neurovascular Stent System
- Keywords
- TRUST Registry, Registry study, Flow Diverter, WallabyPhenox, p48 MW (HPC), p64, Avenir Coil, p64 MW (HPC), pEGASUS HPC, pCONUS 2 (HPC)
- Medical subject headings
- Aneurysm, Aneurysm, False, Constriction, Pathologic, Intracranial Aneurysm, X-Linked Combined Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysm Treatment with a Neurovascular Flow DiverterDevice
Treatment of aneurysms (saccular or fusiform) and pseudoaneurysms with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Dissection Treatment with a Neurovascular Flow DiverterDevice
Treatment of vascular dissections in the acute and chronic phases with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Perforation Treatment with a Neurovascular Flow DiverterDevice
Treatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Arteriovenous Fistula treatment with a Neurovascular Flow DiverterDevice
Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Aneurysm Treatment with Neurovascular Stent SystemDevice
Treatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils.
Atherosclerotic vascular stenosis Treatment with Neurovascular Stent SystemDevice
Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.
Dissection Treatment with Neurovascular Stent SystemDevice
Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
Aneurysm treatment with Bifurcation Aneurysm ImplantDevice
Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
Aneurysm treatment with Avenir Coil SystemDevice
Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.
Arteriovenous fistula treatment with Avenir Coil SystemDevice
Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Intracranial Aneurysm | Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol. Receives: Device: Aneurysm Treatment with a Neurovascular Flow Diverter; Device: Aneurysm Treatment with Neurovascular Stent System; Device: Aneurysm treatment with Bifurcation Aneurysm Implant; Device: Aneurysm treatment with Avenir Coil System | |
| Treatment of Vascular Dissection | Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol. Receives: Device: Dissection Treatment with a Neurovascular Flow Diverter; Device: Dissection Treatment with Neurovascular Stent System | |
| Treatment of Vascular Perforation | Patients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol. Receives: Device: Perforation Treatment with a Neurovascular Flow Diverter | |
| Treatment of Neurovascular Abnormalities | Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.
The cohort originates from one overarching registry protocol. Receives: Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter; Device: Arteriovenous fistula treatment with Avenir Coil System | |
| Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries | Patients undergoing treatment for atherosclerotic vascular stenosis of intracranial arteries with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. Receives: Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbi-mortality
Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS > 2 prior to the procedure.
The scale runs from 0-6 and is presented as below:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Measured: Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.
Secondary outcomes (13)
Performance - Aneurysm Occlusion Rate
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Complete occlusion rate assessed by Core Lab with Raymond-Roy occlusion classification.
Measured: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Incidence of re-canalization/ recurrence/ regrowth compared to procedural outcome assessed by Core Lab.
Measured: The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.
Performance - Aneurysm Re-treatment Rate
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Re-treatment Rate as per investigator's reported data.
Measured: The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.
Performance - Vascular dissections sealing
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Complete sealing of the vascular dissection assessed by Core Lab.
Measured: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Vascular perforation sealing
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Complete sealing of the vascular perforation assessed by Core Lab.
Measured: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Arteriovenous fistula (AVF) Occlusion Status
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
AVF Occlusion status assessed by Core Lab - binary evaluation.
Measured: The performance outcomes is assessed at the end of the procedure at early stage post procedure (5 ± 2 months) and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Incidence of In-stent Stenosis
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Incidence of in-stent stenosis assessed by Core Lab for Neurovascular Flow Diverters and Neurovascular Stent Systems.
Measured: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Device Technical Success
Device Technical success is assessed for each target registry device as per Investigator reported data and defined as successful delivery, positioning, and deployment of the device(s) at the intended target lesion(s).
Measured: Device Technical Success is assessed at the end of the procedure.
Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications
Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome.
Measured: Assessed at relevant time-points (e.g., periprocedural, 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.
Safety - Rate of Major Strokes and Neurological Death
Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.
Measured: Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.
Safety - Incidence of Device deficiencies
Reported Device deficiencies are evaluated as an additional secondary safety outcome.
Measured: Assessed periprocedural and at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.
Usability
Device usability indicator defined upon key functionalities of each device, as well as understanding and handling by the user are evaluated as a Secondary Usability Outcome.
Device key functionalities will be assessed with a 5 grade scale as below:
- Excellent
- Good
- Acceptable
- Unsatisfactory
- Unable to complete
Measured: During the procedure
Performance - Average residual stenosis
Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:
Average residual stenosis assessed by Core Lab by Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) method.
Measured: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start29 Jan 2026
- Primary completionJan 2036 (estimated)
- Study completionJan 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saccular and Fusiform AneurysmsStudies 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Phenox GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474935
- Sponsor's protocol ID
- ST-060
- Acronym
- TRUST
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry
- ClinicalTrials.gov ID
- NCT07474935
- Acronym / sponsor ID
- TRUST / ST-060
- Conditions
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation, Bifurcation Aneurysms, Stenosis
- Keywords
- TRUST Registry, Registry study, Flow Diverter, WallabyPhenox, p48 MW (HPC), p64, Avenir Coil, p64 MW (HPC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Phenox GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2041 (estimated)
- First posted
- 16 Mar 2026 (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.
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.
The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment of Intracranial Aneurysm | – | Device: Aneurysm Treatment with a Neurovascular Flow Diverter, Device: Aneurysm Treatment with Neurovascular Stent System, Device: Aneurysm treatment with Bifurcation Aneurysm Implant, Device: Aneurysm treatment with Avenir Coil SystemPatients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| Treatment of Vascular Dissection | – | Device: Dissection Treatment with a Neurovascular Flow Diverter, Device: Dissection Treatment with Neurovascular Stent SystemPatients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| Treatment of Vascular Perforation | – | Device: Perforation Treatment with a Neurovascular Flow DiverterPatients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| Treatment of Neurovascular Abnormalities | – | Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter, Device: Arteriovenous fistula treatment with Avenir Coil SystemPatients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries | – | Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent SystemPatients undergoing treatment for atherosclerotic vascular stenosis of intracranial arteries with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The registry population comprising of patients suffering from cranial diseases as per indication of target registry devices (intracranial aneurysms, pseudo-aneurysms, neurovascular abnormalities, dissections, perforations, neurovascular abnormalities, and other indication), is deemed representative of the target population in terms of characteristics and standard care.
Key inclusion criteria (2 listed)
- Subject treated or intended to be treated with at least one target registry device during the procedure (i.e., at least one attempt of introduction into the vasculature of the subject),
- Non-opposition to data collection or informed consent provided by the subject or legal representative as per country-specific legislation.
Key exclusion criteria (1 listed)
- Participation in an interventional study modifying standard care management for all relevant indications,
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 |
|---|---|---|
| Aneurysm Treatment with a Neurovascular Flow DiverterTreatment of aneurysms (saccular or fusiform) and pseudoaneurysms with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC. | Device | Treatment of Intracranial Aneurysm |
| Dissection Treatment with a Neurovascular Flow DiverterTreatment of vascular dissections in the acute and chronic phases with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC. | Device | Treatment of Vascular Dissection |
| Perforation Treatment with a Neurovascular Flow DiverterTreatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC. | Device | Treatment of Vascular Perforation |
| Arteriovenous Fistula treatment with a Neurovascular Flow DiverterTreatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC. | Device | Treatment of Neurovascular Abnormalities |
| Aneurysm Treatment with Neurovascular Stent SystemTreatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils. | Device | Treatment of Intracranial Aneurysm |
| Atherosclerotic vascular stenosis Treatment with Neurovascular Stent SystemAtherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC. | Device | Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries |
| Dissection Treatment with Neurovascular Stent SystemTreatment of vascular dissections in the acute and chronic phases with pEGASUS HPC. | Device | Treatment of Vascular Dissection |
| Aneurysm treatment with Bifurcation Aneurysm ImplantTreatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC. | Device | Treatment of Intracranial Aneurysm |
| Aneurysm treatment with Avenir Coil SystemTreatment of intracranial aneurysms with the available variants of the Avenir Coil System. | Device | Treatment of Intracranial Aneurysm |
| Arteriovenous fistula treatment with Avenir Coil SystemTreatment of arteriovenous fistula with the available variants of the Avenir Coil System. | Device | Treatment of Neurovascular Abnormalities |
Primary outcome
Morbi-mortality
Time frame: Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.
Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS > 2 prior to the procedure. The scale runs from 0-6 and is presented as below: 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead
13 secondary outcomes
Performance - Aneurysm Occlusion Rate
Time frame: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth
Time frame: The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.
Performance - Aneurysm Re-treatment Rate
Time frame: The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.
Performance - Vascular dissections sealing
Time frame: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Vascular perforation sealing
Time frame: The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Arteriovenous fistula (AVF) Occlusion Status
Time frame: The performance outcomes is assessed at the end of the procedure at early stage post procedure (5 ± 2 months) and at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Incidence of In-stent Stenosis
Time frame: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Performance - Device Technical Success
Time frame: Device Technical Success is assessed at the end of the procedure.
Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications
Time frame: Assessed at relevant time-points (e.g., periprocedural, 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.
Safety - Rate of Major Strokes and Neurological Death
Time frame: Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.
Safety - Incidence of Device deficiencies
Time frame: Assessed periprocedural and at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.
Usability
Time frame: During the procedure
Performance - Average residual stenosis
Time frame: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.
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 16 Mar 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.
CHU Brest - Hôpital de La Cavale Blanche
Brest, France
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Saccular and Fusiform Aneurysms and Pseudoaneurysm, run by Phenox GmbH at 13 sites in 5 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Italy, France, Switzerland, Slovakia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbi-mortality (time frame: Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.). 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 16 Mar 2026.