Targeting Real World Usage In Stroke Treatment

NCT07474935 | Recruiting

• 1 other identifier: ST-060
• Study Type: observational
• Target: 5,000
• Locations: 5 countries
• Sites: 13

Brief 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

Keywords

TRUST Registry; Registry study; Flow Diverter; WallabyPhenox; p48 MW (HPC); p64; Avenir Coil; p64 MW (HPC); pEGASUS HPC; pCONUS 2 (HPC)

Outcome Measures

Primary Outcomes (1)

• Morbi-mortality

  Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS \> 2 prior to the procedure. The scale runs from 0-6 and is presented as below: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead

  Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.

Secondary Outcomes (13)

• Performance - Aneurysm Occlusion Rate

  The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

• Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth

  The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.

• Performance - Aneurysm Re-treatment Rate

  The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.

• Performance - Vascular dissections sealing

  The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

• Performance - Vascular perforation sealing

  The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Study Arms (5)

Treatment of Intracranial Aneurysm

Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.

Device: Aneurysm Treatment with a Neurovascular Flow Diverter; Device: Aneurysm Treatment with Neurovascular Stent System; Device: Aneurysm treatment with Bifurcation Aneurysm Implant; Device: Aneurysm treatment with Avenir Coil System

Treatment of Vascular Dissection

Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.

Device: Dissection Treatment with a Neurovascular Flow Diverter; Device: Dissection Treatment with Neurovascular Stent System

Treatment of Vascular Perforation

Patients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.

Device: Perforation Treatment with a Neurovascular Flow Diverter

Treatment of Neurovascular Abnormalities

Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.

Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter; Device: Arteriovenous fistula treatment with Avenir Coil System

Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries

Patients undergoing treatment for atherosclerotic vascular stenosis of intracranial arteries with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol.

Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System

Interventions

Aneurysm Treatment with a Neurovascular Flow Diverter DEVICE

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.

Treatment of Intracranial Aneurysm

Dissection Treatment with a Neurovascular Flow Diverter DEVICE

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.

Treatment of Vascular Dissection

Perforation Treatment with a Neurovascular Flow Diverter DEVICE

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

Treatment of Vascular Perforation

Arteriovenous Fistula treatment with a Neurovascular Flow Diverter DEVICE

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

Treatment of Neurovascular Abnormalities

Aneurysm Treatment with Neurovascular Stent System DEVICE

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

Treatment of Intracranial Aneurysm

Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System DEVICE

Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries

Dissection Treatment with Neurovascular Stent System DEVICE

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

Treatment of Vascular Dissection

Aneurysm treatment with Bifurcation Aneurysm Implant DEVICE

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

Treatment of Intracranial Aneurysm

Aneurysm treatment with Avenir Coil System DEVICE

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

Treatment of Intracranial Aneurysm

Arteriovenous fistula treatment with Avenir Coil System DEVICE

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

Treatment of Neurovascular Abnormalities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The registry population comprising of patients suffering from cranial diseases as per indication of target registry devices (intracranial aneurysms, pseudo-aneurysms, neurovascular abnormalities, dissections, perforations, neurovascular abnormalities, and other indication), is deemed representative of the target population in terms of characteristics and standard care.

You may qualify if:

• 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 may not qualify if:

• Participation in an interventional study modifying standard care management for all relevant indications,

Sponsors & Collaborators

• Phenox GmbH: lead

Study Sites (13)

CHU Brest - Hôpital de La Cavale Blanche

Brest, 29200, France

RECRUITING

Pitié Salpêtrière Hospital

Paris, 75013, France

NOT YET RECRUITING

Helios Klinikum Erfurt

Erfurt, 99089, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

LMU Klinikum

München, 81377, Germany

NOT YET RECRUITING

Klinikum Nürnberg

Nuremberg, 90471, Germany

NOT YET RECRUITING

Cannizzaro Hospital in Catania

Catania, 95126, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milano

Milan, 20162, Italy

NOT YET RECRUITING

Antonio Cardarelli Hospital- Naples

Naples, 80131, Italy

NOT YET RECRUITING

Univerzitná nemocnica L. Pasteura Košice

Košice, 040 11, Slovakia

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

NOT YET RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Aneurysm; Aneurysm, False; Constriction, Pathologic; Intracranial Aneurysm; X-Linked Combined Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Severe Combined Immunodeficiency; Primary Immunodeficiency Diseases; Infant, Newborn, Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: March 16, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2041
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

DE (5); SL (1); IT (3); FR (2); CH (2)