TRUST Registry Long-Term Study on Safety and Performance of WallabyPhenox Devices in Stroke and Neurovascular Treatments

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.

Targeting Real World Usage In Stroke Treatment