Targeting Real World Usage In Stroke Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System
  Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.
• Устройство Dissection Treatment with Neurovascular Stent System
  Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
• Устройство Aneurysm treatment with Bifurcation Aneurysm Implant
  Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
• Устройство Aneurysm treatment with Avenir Coil System
  Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.
• Устройство Arteriovenous fistula treatment with Avenir Coil System
  Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Performance - Aneurysm Occlusion Rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.]
• Performance - Device Technical Success [Срок оценки: Device Technical Success is assessed at the end of the procedure.]
• Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 5 центров

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

Италия · 3 центра

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

Франция · 2 центра

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

Швейцария · 2 центра

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

Словакия · 1 центр

• Univerzitná nemocnica L. Pasteura Košice — Košice

Идентификаторы

NCT: NCT07474935 · ST-060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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