Real-world use of WallabyPhenox flow-diversion and stent devices for brain aneurysms and vascular injuries
TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry
Phenox GmbH · NCT07474935
This registry tracks whether WallabyPhenox flow-diverters, stents, and related implants work well and are safe for people treated for brain aneurysms, dissections, pseudoaneurysms, perforations, or related vascular problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Phenox GmbH (industry) |
| Locations | 13 sites (Brest and 12 other locations) |
| Trial ID | NCT07474935 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with intracranial aneurysms, vascular dissections, pseudoaneurysms, perforations, arteriovenous fistulae or related lesions who are being treated or intended to be treated with a WallabyPhenox target device at a participating site and can provide consent or non-opposition to data collection.
Not a fit: Patients enrolled in interventional studies that change standard-of-care management, those not treated with any target registry device, or those who cannot provide consent are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the registry could improve understanding of device safety and performance in everyday practice, helping clinicians choose and use these devices more safely and effectively.
How similar studies have performed: Similar post-market registries and clinical studies of flow-diverter and stent devices have shown effectiveness for many intracranial aneurysms, although outcomes vary by lesion type and device.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brest and 12 other locations
- CHU Brest - Hôpital de La Cavale Blanche — Brest, France (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)
- LMU Klinikum — München, Germany (NOT_YET_RECRUITING)
- Klinikum Nürnberg — Nuremberg, Germany (NOT_YET_RECRUITING)
- Cannizzaro Hospital in Catania — Catania, Italy (NOT_YET_RECRUITING)
- ASST Grande Ospedale Metropolitano Niguarda, Milano — Milan, Italy (NOT_YET_RECRUITING)
- Antonio Cardarelli Hospital- Naples — Naples, Italy (NOT_YET_RECRUITING)
- Univerzitná nemocnica L. Pasteura Košice — Košice, Slovakia (RECRUITING)
- Universitätsspital Basel — Basel, Switzerland (NOT_YET_RECRUITING)
- Kantonsspital St.Gallen — Sankt Gallen, Switzerland (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation, Bifurcation Aneurysms, Stenosis, Neurovascular Abnormalties, Wide-neck Aneurysm