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.
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.
Participation in an interventional study modifying standard care management for all relevant indications,
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.
Cohort
Prospective
Aneurysm Treatment with a Neurovascular Flow Diverter
DeviceTreatment 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 Diverter
DeviceTreatment 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 Diverter
DeviceTreatment 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 Diverter
DeviceTreatment 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 System
DeviceTreatment 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 System
DeviceAtherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.
Dissection Treatment with Neurovascular Stent System
DeviceTreatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.
Aneurysm treatment with Bifurcation Aneurysm Implant
DeviceTreatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.
Aneurysm treatment with Avenir Coil System
DeviceTreatment of intracranial aneurysms with the available variants of the Avenir Coil System.
Arteriovenous fistula treatment with Avenir Coil System
DeviceTreatment of arteriovenous fistula with the available variants of the Avenir Coil System.
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
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.
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.
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.
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