Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:02 PM
Study NCT ID:
NCT07339358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Performance of the World Medica World Diverter Embolization Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'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': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety - Major Adverse Events (MAEs)', 'timeFrame': '12 months', 'description': 'Composite incidence of the following events:\n\n* Major stroke (NIHSS increase of \\> 4) within 30 days post-procedure, defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting \\> 24 hours with no apparent cause other than of vascular origin, including ischemic stroke or hemorrhagic stroke \\[i.e., intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hemorrhage (SDH), epidural hemorrhage (EDH)\\] accompanied with radiological evidence\n* Major ipsilateral stroke within 12 months post-procedure, defined as a major stroke (as defined above) occurring within the vascular distribution of the target artery\n* Neurological death within 12 months, defined as a death which directly resulted from a neurologic cause.'}, {'measure': 'Primary Effectiveness - Complete Occlusion', 'timeFrame': '12 months', 'description': 'The proportion of subjects with all of the following:\n\n* Complete (100%) occlusion of the target IA (Raymond-Roy Class I)\n* ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography at 12 months post-procedure\n* No subsequent treatment of the target IA within 12 months post-procedure.'}], 'secondaryOutcomes': [{'measure': 'Medium-Term Effectiveness', 'timeFrame': '6 months', 'description': 'Complete IA occlusion'}, {'measure': 'Medium-Term Parent Artery Stenosis', 'timeFrame': '6 months', 'description': 'Parent Artery Stenosis'}, {'measure': 'Medium-Term Functional Outcomes', 'timeFrame': '6 months', 'description': 'Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline'}, {'measure': 'Secondary Effectiveness - Adequate Occlusion', 'timeFrame': '12 months', 'description': 'The proportion of subjects with all of the following:\n\n* Adequate occlusion of the target IA (Raymond-Roy Class I or II)\n* ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography 12 months post-procedure\n* No subsequent treatment of the target IA within 12 months post-procedure'}, {'measure': 'Long-Term Angiographic Outcome', 'timeFrame': '12 months', 'description': 'Raymond-Roy IA classifications'}, {'measure': 'Long-Term Parent Artery Stenosis', 'timeFrame': '12 months', 'description': 'Parent Artery Stenosis'}, {'measure': 'Long-Term Functional Outcome', 'timeFrame': '12 months', 'description': 'Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \\<2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 22 to 80 years\n* Subject, or subject's legal representative provided informed consent\n* Subject agrees to the requirements of the study, including returning for required follow-up visits\n* Parent artery diameter of 2.0-5.5 mm distal and proximal to the target IA\n* Subject has a single target IA in the index procedure with the following characteristics: (1) Unruptured; (2) Located in the ICA from the petrous through the superior hypophyseal segments; and (3) Is a fusiform or saccular wide-necked IA with one of the following characteristics: (a) Small (\\< 5 mm) or medium (\\>5-10 mm) size with a neck width ≥ 4.0 mm or a dome-to-neck ratio of \\< 2; OR (b) Large (\\>10-25 mm) or giant (\\>25 mm) size\n\nExclusion Criteria:\n\n* A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure\n* A bleeding disorder or a platelet count of less than 100x103/mm3 or INR \\>1.5\n* A contraindication to or inability to tolerate antiplatelet therapy\n* An allergy to radiographic contrast agents\n* An allergy to  nickel, titanium, platinum, tungsten, or stainless steel\n* An allergy to local or general anesthesia\n* A history of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke risk factors\n* A history of deep vein thrombosis or pulmonary embolism\n* A history of heart failure, dilated cardiomyopathy, or congenital heart conditions\n* Hypercoagulopathy or a hemorrhagic or coagulation deficiency refractory to medical therapy or subject refuses treatment with blood products\n* Suffered a stroke within 180 days preceding the index procedure\n* Had major surgery within the 30 days preceding or planned for the 180 days following the index procedure, including but not limited to intracranial stenting or coiling\n* Target aneurysm has been previously treated with clipping, coiling, or flow diversion\n* Had previous stenting of or implant in parent artery proximal to the target aneurysm that could interfere with delivery or performance of study device\n* Asymptomatic extradural aneurysms requiring treatment\n* Contraindication to computed tomography (CT) or magnetic resonance (MR)\n* An unstable neurological deficit (i.e., worsening of a clinical condition within the 30 days preceding the index procedure)\n* Evidence of an active systemic infection (including COVID-19) at index procedure\n* Dementia or other cognitive condition limiting their ability to participate in the study\n* A condition that may limit survival to less than 12 months post-index procedure\n* Serum creatinine ≥2.5 mg/dL\n* Had radiation or chemotherapy treatment either currently or within the 60 days preceding the index procedure\n* Current enrollment in a separate clinical trial\n* Another condition(s) that, in the opinion of the Investigator, could interfere with the ability to perform a safe or effective procedure\n* Current pregnancy or plan to become pregnant within the 12 months following the index procedure, or be currently breastfeeding\n\nAngiographic Exclusion Criteria:\n\n* Anatomy not amenable to endovascular treatment, including but not limited to severe vessel tortuosity or stenosis\n* Parent vessel stenosis is \\>50% in the target area\n* Extracranial stenosis of the carotid artery \\>50%\n* An intracranial mass\n* More than one vessel segment requiring IA treatment in the 12 months following the index procedure\n* Target aneurysm is mycotic or dissecting\n* Target aneurysm is at bifurcation\n* Target aneurysm will require coiling in addition to flow diversion, in Investigator's opinion"}, 'identificationModule': {'nctId': 'NCT07339358', 'briefTitle': 'Safety & Performance of the World Medica World Diverter Embolization Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'World Medica USA, LLC'}, 'officialTitle': 'Safety & Performance of the World Medica World Diverter Embolization Device', 'orgStudyIdInfo': {'id': 'CIP-001WM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'World Diverter Implantation', 'interventionNames': ['Device: Flow diverter implantation']}], 'interventions': [{'name': 'Flow diverter implantation', 'type': 'DEVICE', 'description': 'Implantation of the World Diverter Embolization Device', 'armGroupLabels': ['World Diverter Implantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Alejandro Tomasello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Vall d'Hebron"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are protected by data privacy laws and are only provided for the purposes of this study following provision of participant informed consent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'World Medica USA, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}