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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of Intracranial Aneurysm | Patients undergoing treatment for intracranial aneurysms (IA) with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| |
| Treatment of Vascular Dissection | Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| |
| Treatment of Vascular Perforation | Patients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| |
| Treatment of Neurovascular Abnormalities | Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aneurysm Treatment with a Neurovascular Flow Diverter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest - Hôpital de La Cavale Blanche | Recruiting | Brest | 29200 | France |
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| Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries | Patients undergoing treatment for atherosclerotic vascular stenosis of intracranial arteries with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals. The cohort originates from one overarching registry protocol. |
|
| Dissection Treatment with a Neurovascular Flow Diverter | Device | 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 Diverter | Device | 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 Diverter | Device | 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 System | Device | 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 System | Device | Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC. |
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| Dissection Treatment with Neurovascular Stent System | Device | Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC. |
|
| Aneurysm treatment with Bifurcation Aneurysm Implant | Device | Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC. |
|
| Aneurysm treatment with Avenir Coil System | Device | Treatment of intracranial aneurysms with the available variants of the Avenir Coil System. |
|
| Arteriovenous fistula treatment with Avenir Coil System | Device | Treatment of arteriovenous fistula with the available variants of the Avenir Coil System. |
|
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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:
| 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. | The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites. |
| Pitié Salpêtrière Hospital | Not yet recruiting | Paris | 75013 | France |
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| Helios Klinikum Erfurt | Not yet recruiting | Erfurt | 99089 | Germany |
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| Universitätsklinikum Hamburg-Eppendorf | Not yet recruiting | Hamburg | 20246 | Germany |
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| University Hospital Heidelberg | Not yet recruiting | Heidelberg | 69120 | Germany |
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| LMU Klinikum | Not yet recruiting | München | 81377 | Germany |
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| Klinikum Nürnberg | Not yet recruiting | Nuremberg | 90471 | Germany |
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| Cannizzaro Hospital in Catania | Not yet recruiting | Catania | 95126 | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda, Milano | Not yet recruiting | Milan | 20162 | Italy |
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| Antonio Cardarelli Hospital- Naples | Not yet recruiting | Naples | 80131 | Italy |
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| Univerzitná nemocnica L. Pasteura Košice | Recruiting | Košice | 040 11 | Slovakia |
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| Universitätsspital Basel | Not yet recruiting | Basel | 4031 | Switzerland |
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| Kantonsspital St.Gallen | Not yet recruiting | Sankt Gallen | 9007 | Switzerland |
|
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D017541 | Aneurysm, False |
| D003251 | Constriction, Pathologic |
| D002532 | Intracranial Aneurysm |
| D053632 | X-Linked Combined Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016511 | Severe Combined Immunodeficiency |
| D000081207 | Primary Immunodeficiency Diseases |
| D007232 | Infant, Newborn, Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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