An observational study in Saccular and Fusiform Aneurysms, Pseudoaneurysm and Vascular Dissection, sponsored by Phenox GmbH. Recruiting at 13 sites in 5 countries. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Phenox GmbH · Observational
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Phenox GmbH is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Compared within Intracranial Aneurysm, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Device: Dissection Treatment with a Neurovascular Flow Diverter · Device: Dissection Treatment with Neurovascular Stent System
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.
Device: Perforation Treatment with a Neurovascular Flow Diverter
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.
Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter · Device: Arteriovenous fistula treatment with Avenir Coil System
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.
Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System
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.
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.
Treatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
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 of intracranial arteries treated with pEGASUS HPC.
Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.
Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.
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. 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
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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).
Time frame: 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.
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
Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.
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
Reported Device deficiencies are evaluated as an additional secondary safety outcome.
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
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
Time frame: 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.
Time frame: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Phenox GmbH