Targeting Real World Usage In Stroke Treatment

Phenox GmbH5,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Saccular and Fusiform Aneurysms Pseudoaneurysm Vascular Dissection Perforation Bifurcation Aneurysms Stenosis Neurovascular Abnormalties

Interventions

Aneurysm Treatment with a Neurovascular Flow DiverterDEVICE

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.

Dissection Treatment with a Neurovascular Flow DiverterDEVICE

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.

Perforation Treatment with a Neurovascular Flow DiverterDEVICE

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

Arteriovenous Fistula treatment with a Neurovascular Flow DiverterDEVICE

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

Aneurysm Treatment with Neurovascular Stent SystemDEVICE

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

Atherosclerotic vascular stenosis Treatment with Neurovascular Stent SystemDEVICE

Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

Dissection Treatment with Neurovascular Stent SystemDEVICE

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

Aneurysm treatment with Bifurcation Aneurysm ImplantDEVICE

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

Aneurysm treatment with Avenir Coil SystemDEVICE

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

Arteriovenous fistula treatment with Avenir Coil SystemDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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,

Locations (13)

CHU Brest - Hôpital de La Cavale Blanche

Brest, France

RECRUITING

Pitié Salpêtrière Hospital

Paris, France

NOT_YET_RECRUITING

Helios Klinikum Erfurt

Erfurt, Germany

NOT_YET_RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

NOT_YET_RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

NOT_YET_RECRUITING

LMU Klinikum

München, Germany

NOT_YET_RECRUITING

Klinikum Nürnberg

Nuremberg, Germany

NOT_YET_RECRUITING

Cannizzaro Hospital in Catania

Catania, Italy

NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milano

Milan, Italy

NOT_YET_RECRUITING

Antonio Cardarelli Hospital- Naples

Naples, Italy

NOT_YET_RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

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

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 Outcomes

Performance - Aneurysm Occlusion Rate

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete occlusion rate assessed by Core Lab with Raymond-Roy occlusion classification.

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

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Incidence of re-canalization/ recurrence/ regrowth compared to procedural outcome assessed by Core Lab.

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

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Re-treatment Rate as per investigator's reported data.

Performance - Vascular dissections sealing

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete sealing of the vascular dissection assessed by Core Lab.

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

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete sealing of the vascular perforation assessed by Core Lab.

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

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: AVF Occlusion status assessed by Core Lab - binary evaluation.

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

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Incidence of in-stent stenosis assessed by Core Lab for Neurovascular Flow Diverters and Neurovascular Stent Systems.

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

Device Technical success is assessed for each target registry device as per Investigator reported data and defined as successful delivery, positioning, and deployment of the device(s) at the intended target lesion(s).

Time frame: Device Technical Success is assessed at the end of the procedure.

Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications

Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome.

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

Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.

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

Reported Device deficiencies are evaluated as an additional secondary safety outcome.

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

Device usability indicator defined upon key functionalities of each device, as well as understanding and handling by the user are evaluated as a Secondary Usability Outcome. Device key functionalities will be assessed with a 5 grade scale as below: * Excellent * Good * Acceptable * Unsatisfactory * Unable to complete

Time frame: During the procedure

Performance - Average residual stenosis

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Average residual stenosis assessed by Core Lab by Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) method.

Time frame: The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.