RecruitingNCT07474935

Targeting Real World Usage In Stroke Treatment

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


Sponsor

Phenox GmbH

Enrollment

5,000 participants

Start Date

Jan 29, 2026

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Inclusion Criteria2

  • 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 Criteria1

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

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Interventions

DEVICEAneurysm 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.

DEVICEDissection 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.

DEVICEPerforation 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.

DEVICEArteriovenous 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.

DEVICEAneurysm 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.

DEVICEAtherosclerotic vascular stenosis Treatment with Neurovascular Stent System

Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

DEVICEDissection Treatment with Neurovascular Stent System

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

DEVICEAneurysm treatment with Bifurcation Aneurysm Implant

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

DEVICEAneurysm treatment with Avenir Coil System

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

DEVICEArteriovenous fistula treatment with Avenir Coil System

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


Locations(13)

CHU Brest - Hôpital de La Cavale Blanche

Brest, France

Pitié Salpêtrière Hospital

Paris, France

Helios Klinikum Erfurt

Erfurt, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

University Hospital Heidelberg

Heidelberg, Germany

LMU Klinikum

München, Germany

Klinikum Nürnberg

Nuremberg, Germany

Cannizzaro Hospital in Catania

Catania, Italy

ASST Grande Ospedale Metropolitano Niguarda, Milano

Milan, Italy

Antonio Cardarelli Hospital- Naples

Naples, Italy

Univerzitná nemocnica L. Pasteura Košice

Košice, Slovakia

Universitätsspital Basel

Basel, Switzerland

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

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NCT07474935


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