Actively Recruiting
TRUST Registry Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry
Led by Phenox GmbH · Updated on 2026-03-16
5000
Participants Needed
13
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This registry observes patients treated with WallabyPhenox flow modulation devices and other related implantable devices for various neurovascular conditions such as intracranial aneurysms, vascular dissection, vascular perforation, neurovascular abnormalities, and atherosclerotic vascular stenosis of intracranial arteries. The aim is to proactively collect and analyze data on the safety, performance, and usability of these devices as used in routine medical practice. Participants receive treatment with approved WallabyPhenox devices, including neurovascular flow diverters, stent systems, bifurcation aneurysm implants, and coil systems, tailored to their specific vascular condition. Treatments follow standard care practices at participating hospitals, covering conditions like aneurysms, dissections, perforations, fistulas, and stenosis. Various device types such as p64, p48 MW variants, pEGASUS HPC, pCONUS 2, and Avenir Coil System are included depending on the condition treated. During the registry, data will be gathered on morbi-mortality related to the devices and procedures up to 365 days post-treatment, as well as performance measures like aneurysm occlusion rates, device technical success, vascular sealing, and incidence of complications at multiple time points up to five years. Safety outcomes including strokes, neurological death, and device deficiencies will also be tracked. All assessments align with the standard care schedules at the participating sites, aiming to understand the real-world use and effectiveness of these devices over the long term.
CONDITIONS
Brief Title
Targeting Real World Usage In Stroke Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Participation in an interventional study modifying standard care management for all relevant indications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on individual treatment and condition
Participants receive treatment of various neurovascular conditions using market-approved WallabyPhenox implantable devices as part of routine care in participating hospitals.
1 treatment visit (in-person)
Duration - Up to 5 years post-treatment
Participants are monitored for safety and performance outcomes of the devices following treatment, including assessments aligned with standard care up to 5 years post-procedure.
Follow-up visits at multiple timepoints up to 5 years post-procedure as per standard care
Trial Site Locations
Total: 13 locations
1
CHU Brest - Hôpital de La Cavale Blanche
Brest, France, 29200
Actively Recruiting
2
Pitié Salpêtrière Hospital
Paris, France, 75013
Not Yet Recruiting
3
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Not Yet Recruiting
4
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
5
University Hospital Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
6
LMU Klinikum
München, Germany, 81377
Not Yet Recruiting
7
Klinikum Nürnberg
Nuremberg, Germany, 90471
Not Yet Recruiting
8
Cannizzaro Hospital in Catania
Catania, Italy, 95126
Not Yet Recruiting
9
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milan, Italy, 20162
Not Yet Recruiting
10
Antonio Cardarelli Hospital- Naples
Naples, Italy, 80131
Not Yet Recruiting
11
Univerzitná nemocnica L. Pasteura Košice
Košice, Slovakia, 040 11
Actively Recruiting
12
Universitätsspital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
13
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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