Targeting Real World Usage In Stroke Treatment (TRUST)

March 11, 2026 updated by: Phenox GmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
      • Paris, France, 75013
  • Germany
  • Italy
      • Catania, Italy, 95126
        • Not yet recruiting
        • Cannizzaro Hospital in Catania
        • Contact:
        • Sub-Investigator:
          • Concetto CRISTAUDO, Prof.
      • Milan, Italy, 20162
      • Napoli, Italy, 80131
        • Not yet recruiting
        • Antonio Cardarelli Hospital- Naples
        • Contact:
          • Mario MUTO, Prof.
        • Sub-Investigator:
          • Amedeo CERVO, Dr.
  • Slovakia
      • Košice, Slovakia, 040 11
        • Recruiting
        • Univerzitna nemocnica L. Pasteura Kosice
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
      • Sankt Gallen, Switzerland, 9007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participation in an interventional study modifying standard care management for all relevant indications,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Aneurysm Treatment with a Neurovascular Flow Diverter
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.
Device: Aneurysm Treatment with Neurovascular Stent System
Treatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils.
Device: Aneurysm treatment with Bifurcation Aneurysm Implant
Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
Device: Aneurysm treatment with Avenir Coil System
Treatment of intracranial aneurysms with the available variants of the 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.
Device: Dissection Treatment with a Neurovascular Flow Diverter
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.
Device: Dissection Treatment with Neurovascular Stent System
Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
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.
Device: Perforation Treatment with a Neurovascular Flow Diverter
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 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.
Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter
Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.
Device: Arteriovenous fistula treatment with Avenir Coil System
Treatment of arteriovenous fistula with the available variants of the 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.
Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System
Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.
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).
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.
Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome.
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.
Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.
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.
Reported Device deficiencies are evaluated as an additional secondary safety outcome.
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

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
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.

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.
The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phenox GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

January 1, 2041

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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