Targeting Real World Usage In Stroke Treatment

Summary

TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.

The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.

Conditions

• Saccular and Fusiform Aneurysms
• Pseudoaneurysm
• Vascular Dissection
• Perforation
• Bifurcation Aneurysms
• Stenosis
• Neurovascular Abnormalties
• Wide-neck Aneurysm
• Intracranial Aneurysms

Interventions

DEVICE

Perforation Treatment with a Neurovascular Flow Diverter

Treatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

DEVICE

Dissection Treatment with Neurovascular Stent System

Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.

DEVICE

Arteriovenous Fistula treatment with a Neurovascular Flow Diverter

Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

DEVICE

Aneurysm Treatment with Neurovascular Stent System

Treatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils.

DEVICE

Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System

Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

DEVICE

Aneurysm Treatment with a Neurovascular Flow Diverter

Treatment of aneurysms (saccular or fusiform) and pseudoaneurysms with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

DEVICE

Dissection Treatment with a Neurovascular Flow Diverter

Treatment of vascular dissections in the acute and chronic phases with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

DEVICE

Aneurysm treatment with Bifurcation Aneurysm Implant

Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.

DEVICE

Aneurysm treatment with Avenir Coil System

Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.

DEVICE

Arteriovenous fistula treatment with Avenir Coil System

Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.

Sponsors & Collaborators

• Phenox GmbH

  lead INDUSTRY

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-29

Primary Completion

2036-01-31

Completion

2041-01-31

Countries

• France
• Germany
• Italy
• Slovakia
• Switzerland

Study Locations