Actively Recruiting

All Genders
ID07474935

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

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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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Long-term Monitoring

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

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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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