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NCT Number: NCT07474935

Targeting Real World Usage In Stroke Treatment

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.

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Key information

Conditions

Saccular and Fusiform Aneurysms Aneurysm Aneurysm, False Bifurcation Aneurysms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Genetic Diseases, Inborn Genetic Diseases, X-Linked Immune System Diseases Immunologic Deficiency Syndromes Infant, Newborn, Diseases Intracranial Aneurysm Intracranial Aneurysms Intracranial Arterial Diseases Nervous System Diseases Neurovascular Abnormalties Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perforation Primary Immunodeficiency Diseases Pseudoaneurysm Severe Combined Immunodeficiency Stenosis Vascular Diseases Vascular Dissection Wide-neck Aneurysm X-Linked Combined Immunodeficiency Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brest - Hôpital de La Cavale Blanche, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Aneurysm Treatment with a Neurovascular Flow Diverter

Device

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 Diverter

Device

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 Diverter

Device

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 Diverter

Device

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 System

Device

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 System

Device

Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

Dissection Treatment with Neurovascular Stent System

Device

Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.

Aneurysm treatment with Bifurcation Aneurysm Implant

Device

Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.

Aneurysm treatment with Avenir Coil System

Device

Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.

Arteriovenous fistula treatment with Avenir Coil System

Device

Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.

Primary outcomes

  1. 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.

    • - 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

Sponsors and collaborators

Lead sponsor

Phenox GmbH

Industry

Registry information

Official study title

TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry

Acronym: TRUST

Important dates

Study start
2026
Primary completion
2036
Study completion
2041
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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