Bifurcation Aneurysms, Intracranial Aneurysms, Neurovascular Abnormalties, Perforation, Pseudoaneurysm, Saccular and Fusiform Aneurysms, Stenosis, Vascular Dissection, Wide-neck Aneurysm
Conditions
Keywords
TRUST Registry, Registry study, Flow Diverter, WallabyPhenox, p48 MW (HPC), p64, Avenir Coil, p64 MW (HPC), pEGASUS HPC, pCONUS 2 (HPC)
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.
Interventions
DEVICEAneurysm 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.
DEVICEDissection 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.
DEVICEPerforation 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.
DEVICEArteriovenous 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.
DEVICEAneurysm 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.
DEVICEAtherosclerotic vascular stenosis Treatment with Neurovascular Stent System
Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.
DEVICEDissection Treatment with Neurovascular Stent System
Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
DEVICEAneurysm treatment with Bifurcation Aneurysm Implant
Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
DEVICEAneurysm treatment with Avenir Coil System
Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.
DEVICEArteriovenous fistula treatment with Avenir Coil System
Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.
Sponsors
Phenox GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbi-mortality | Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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 | 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. | 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. |
| 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. | 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. |
| Performance - Arteriovenous fistula (AVF) Occlusion Status | 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. | 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. |
| Performance - Incidence of In-stent Stenosis | The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites. | 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. |
| Performance - Device Technical Success | Device Technical Success is assessed at the end of the procedure. | 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). |
| Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications | 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. | Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome. |
| Safety - Rate of Major Strokes and Neurological Death | Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure. | Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome. |
| Safety - Incidence of Device deficiencies | 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. | Reported Device deficiencies are evaluated as an additional secondary safety outcome. |
| Usability | During the procedure | 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 |
| Performance - Average residual stenosis | The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites. | 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. |
Countries
France, Germany, Italy, Slovakia, Switzerland
Outcome results
None listed