Real-world use of WallabyPhenox flow-diversion and stent devices for brain aneurysms and vascular injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TRUST is a prospective, observational post-market registry that collects long-term safety, performance, and usability data on WallabyPhenox flow-modulation devices, stent systems, bifurcation implants (including HPC-coated variants), coils, and adjunctive devices as used in routine clinical practice. Patients are enrolled when treated or intended to be treated with at least one target device, with data gathered across participating centers without changing standard care. The registry aims to capture real-world outcomes across a range of neurovascular indications including saccular and fusiform aneurysms, pseudoaneurysms, dissections, perforations, and arteriovenous fistulae. Data from multiple sites will be used to characterize device performance, complications, and device usability over time.

Why it matters

Who can join: the full rules

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,

Where it's running

• CHU Brest - Hôpital de La Cavale Blanche
  Brest, France Recruiting
• Univerzitná nemocnica L. Pasteura Košice
  Košice, Slovakia Recruiting
• Pitié Salpêtrière Hospital
  Paris, France Not yet recruiting
• Helios Klinikum Erfurt
  Erfurt, Germany Not yet recruiting
• Universitätsklinikum Hamburg-Eppendorf
  Hamburg, Germany Not yet recruiting
• University Hospital Heidelberg
  Heidelberg, Germany Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.