Targeting Real World Usage In Stroke Treatment

Official title

TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry

Overview

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.

Interventions

• 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 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 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 Dissection Treatment with Neurovascular Stent System
  Treatment of vascular dissections in the acute and chronic phases with pEGASUS 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.

Primary outcome measures

• Morbi-mortality [Time frame: 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 outcome measures (12)

• Performance - Aneurysm Occlusion Rate [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 - Arteriovenous fistula (AVF) Occlusion Status [Time frame: The performance outcomes is assessed at the end of the procedure at early stage post procedure (5 ± 2 months) and at 12 months (± 6 months) in alignment with the standard of care of participating sites.]
• Performance - Incidence of In-stent Stenosis [Time frame: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.]
• Performance - Device Technical Success [Time frame: Device Technical Success is assessed at the end of the procedure.]
• Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications [Time frame: Assessed at relevant time-points (e.g., periprocedural, 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.]
• Safety - Rate of Major Strokes and Neurological Death [Time frame: Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.]
• Safety - Incidence of Device deficiencies [Time frame: Assessed periprocedural and 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.]
• Usability [Time frame: During the procedure]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 5 centers

• Helios Klinikum Erfurt — Erfurt
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• University Hospital Heidelberg — Heidelberg
• LMU Klinikum — München
• Klinikum Nürnberg — Nuremberg

Italy · 3 centers

• Cannizzaro Hospital in Catania — Catania
• ASST Grande Ospedale Metropolitano Niguarda, Milano — Milan
• Antonio Cardarelli Hospital- Naples — Naples

France · 2 centers

• CHU Brest - Hôpital de La Cavale Blanche — Brest
• Pitié Salpêtrière Hospital — Paris

Switzerland · 2 centers

• Universitätsspital Basel — Basel
• Kantonsspital St.Gallen — Sankt Gallen

Slovakia · 1 center

• Univerzitná nemocnica L. Pasteura Košice — Košice

Identifiers

NCT: NCT07474935 · ST-060

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗