Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:37 PM
Study NCT ID:
NCT07474935
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Real World Usage In Stroke Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D017541', 'term': 'Aneurysm, False'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D053632', 'term': 'X-Linked Combined Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016511', 'term': 'Severe Combined Immunodeficiency'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2041-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbi-mortality', 'timeFrame': 'Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.', 'description': '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.\n\nThe scale runs from 0-6 and is presented as below:\n\n0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead'}], 'secondaryOutcomes': [{'measure': 'Performance - Aneurysm Occlusion Rate', 'timeFrame': '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.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nComplete occlusion rate assessed by Core Lab with Raymond-Roy occlusion classification.'}, {'measure': 'Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth', 'timeFrame': '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.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nIncidence of re-canalization/ recurrence/ regrowth compared to procedural outcome assessed by Core Lab.'}, {'measure': 'Performance - Aneurysm Re-treatment Rate', 'timeFrame': '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.', 'description': "Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nRe-treatment Rate as per investigator's reported data."}, {'measure': 'Performance - Vascular dissections sealing', 'timeFrame': '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.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nComplete sealing of the vascular dissection assessed by Core Lab.'}, {'measure': 'Performance - Vascular perforation sealing', 'timeFrame': '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.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nComplete sealing of the vascular perforation assessed by Core Lab.'}, {'measure': 'Performance - Arteriovenous fistula (AVF) Occlusion Status', 'timeFrame': '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.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nAVF Occlusion status assessed by Core Lab - binary evaluation.'}, {'measure': 'Performance - Incidence of In-stent Stenosis', 'timeFrame': 'The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nIncidence of in-stent stenosis assessed by Core Lab for Neurovascular Flow Diverters and Neurovascular Stent Systems.'}, {'measure': 'Performance - Device Technical Success', 'timeFrame': 'Device Technical Success is assessed at the end of the procedure.', 'description': '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).'}, {'measure': 'Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications', 'timeFrame': '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.', 'description': 'Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome.'}, {'measure': 'Safety - Rate of Major Strokes and Neurological Death', 'timeFrame': 'Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.', 'description': 'Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.'}, {'measure': 'Safety - Incidence of Device deficiencies', 'timeFrame': '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.', 'description': 'Reported Device deficiencies are evaluated as an additional secondary safety outcome.'}, {'measure': 'Usability', 'timeFrame': 'During the procedure', 'description': '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.\n\nDevice key functionalities will be assessed with a 5 grade scale as below:\n\n* Excellent\n* Good\n* Acceptable\n* Unsatisfactory\n* Unable to complete'}, {'measure': 'Performance - Average residual stenosis', 'timeFrame': 'The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.', 'description': 'Assessment of the performance of devices in the light of relevant state-of-the-art performance measures:\n\nAverage residual stenosis assessed by Core Lab by Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRUST Registry', 'Registry study', 'Flow Diverter', 'WallabyPhenox', 'p48 MW (HPC)', 'p64', 'Avenir Coil', 'p64 MW (HPC)', 'pEGASUS HPC', 'pCONUS 2 (HPC)'], 'conditions': ['Saccular and Fusiform Aneurysms', 'Pseudoaneurysm', 'Vascular Dissection', 'Perforation', 'Bifurcation Aneurysms', 'Stenosis', 'Neurovascular Abnormalties', 'Wide-neck Aneurysm', 'Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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),\n* Non-opposition to data collection or informed consent provided by the subject or legal representative as per country-specific legislation.\n\nExclusion Criteria:\n\n* Participation in an interventional study modifying standard care management for all relevant indications,'}, 'identificationModule': {'nctId': 'NCT07474935', 'acronym': 'TRUST', 'briefTitle': 'Targeting Real World Usage In Stroke Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Phenox GmbH'}, 'officialTitle': 'TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry', 'orgStudyIdInfo': {'id': 'ST-060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment of Intracranial Aneurysm', 'description': '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.\n\nThe cohort originates from one overarching registry protocol.', 'interventionNames': ['Device: Aneurysm Treatment with a Neurovascular Flow Diverter', 'Device: Aneurysm Treatment with Neurovascular Stent System', 'Device: Aneurysm treatment with Bifurcation Aneurysm Implant', 'Device: Aneurysm treatment with Avenir Coil System']}, {'label': 'Treatment of Vascular Dissection', 'description': 'Patients undergoing treatment for vascular dissection with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.\n\nThe cohort originates from one overarching registry protocol.', 'interventionNames': ['Device: Dissection Treatment with a Neurovascular Flow Diverter', 'Device: Dissection Treatment with Neurovascular Stent System']}, {'label': 'Treatment of Vascular Perforation', 'description': 'Patients undergoing treatment for vascular perforation with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.\n\nThe cohort originates from one overarching registry protocol.', 'interventionNames': ['Device: Perforation Treatment with a Neurovascular Flow Diverter']}, {'label': 'Treatment of Neurovascular Abnormalities', 'description': 'Patients undergoing treatment for neurovascular abnormalities with market approved device(s) from WallabyPhenox implantable devices portfolio as per standard of care of participating hospitals.\n\nThe cohort originates from one overarching registry protocol.', 'interventionNames': ['Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter', 'Device: Arteriovenous fistula treatment with Avenir Coil System']}, {'label': 'Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries', 'description': '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.', 'interventionNames': ['Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System']}], 'interventions': [{'name': 'Aneurysm Treatment with a Neurovascular Flow Diverter', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment of Intracranial Aneurysm']}, {'name': 'Dissection Treatment with a Neurovascular Flow Diverter', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment of Vascular Dissection']}, {'name': 'Perforation Treatment with a Neurovascular Flow Diverter', 'type': 'DEVICE', 'description': 'Treatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.', 'armGroupLabels': ['Treatment of Vascular Perforation']}, {'name': 'Arteriovenous Fistula treatment with a Neurovascular Flow Diverter', 'type': 'DEVICE', 'description': 'Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.', 'armGroupLabels': ['Treatment of Neurovascular Abnormalities']}, {'name': 'Aneurysm Treatment with Neurovascular Stent System', 'type': 'DEVICE', 'description': 'Treatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils.', 'armGroupLabels': ['Treatment of Intracranial Aneurysm']}, {'name': 'Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System', 'type': 'DEVICE', 'description': 'Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.', 'armGroupLabels': ['Treatment of Atherosclerotic Vascular Stenosis of Intracranial Arteries']}, {'name': 'Dissection Treatment with Neurovascular Stent System', 'type': 'DEVICE', 'description': 'Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.', 'armGroupLabels': ['Treatment of Vascular Dissection']}, {'name': 'Aneurysm treatment with Bifurcation Aneurysm Implant', 'type': 'DEVICE', 'description': 'Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.', 'armGroupLabels': ['Treatment of Intracranial Aneurysm']}, {'name': 'Aneurysm treatment with Avenir Coil System', 'type': 'DEVICE', 'description': 'Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.', 'armGroupLabels': ['Treatment of Intracranial Aneurysm']}, {'name': 'Arteriovenous fistula treatment with Avenir Coil System', 'type': 'DEVICE', 'description': 'Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.', 'armGroupLabels': ['Treatment of Neurovascular Abnormalities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe GENTRIC, Prof. Dr.', 'role': 'CONTACT', 'email': 'jean-christophe.gentric@chu-brest.fr', 'phone': '+33 2 98 34 74 87'}], 'facility': 'CHU Brest - Hôpital de La Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric CLARENÇON, Prof. Dr.', 'role': 'CONTACT', 'email': 'frederic.clarencon@aphp.fr'}], 'facility': 'Pitié Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '99089', 'city': 'Erfurt', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim KLISCH, Prof.', 'role': 'CONTACT', 'email': 'joachim.klisch@helios-gesundheit.de'}], 'facility': 'Helios Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maxim BESTER, PD. Dr.', 'role': 'CONTACT', 'email': 'm.bester@uke.de'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus MÖHLENBRUCH, Prof.', 'role': 'CONTACT', 'email': 'markus.moehlenbruch@med.uni-heidelberg.de'}], 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '81377', 'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas LIEBIG, Prof. Dr.', 'role': 'CONTACT', 'email': 'Thomas.Liebig@med.uni-muenchen.de'}], 'facility': 'LMU Klinikum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '90471', 'city': 'Nuremberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus HOLTMANNSPÖTTER, Dr.', 'role': 'CONTACT', 'email': 'Markus.Holtmannspoetter@klinikum-nuernberg.de'}], 'facility': 'Klinikum Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '95126', 'city': 'Catania', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guglielmo PERO, Dr.', 'role': 'CONTACT', 'email': 'Guglielmo.pero@gmail.com'}, {'name': 'Concetto CRISTAUDO, Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cannizzaro Hospital in Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '20162', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mariangela PIANO, Dr.', 'role': 'CONTACT', 'email': 'mariangela.piano@ospedaleniguarda.it'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda, Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Naples', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario MUTO, Prof.', 'role': 'CONTACT'}, {'name': 'Amedeo CERVO, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antonio Cardarelli Hospital- Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '040 11', 'city': 'Košice', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Piotr PEDOWSKI, Dr.', 'role': 'CONTACT', 'email': 'piotr.pedowski@unlp.sk', 'phone': '+42155640 4213'}], 'facility': 'Univerzitná nemocnica L. Pasteura Košice', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '4031', 'city': 'Basel', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Marios-Nikos PSYCHOGIOS, Prof.', 'role': 'CONTACT', 'email': 'marios.psychogios@usb.ch'}], 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '9007', 'city': 'Sankt Gallen', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Victoria HELLSTERN, Dr.', 'role': 'CONTACT', 'email': 'victoria.hellstern@h-och.ch'}], 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phenox GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}