Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT04315168
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '1 year', 'description': 'Percentage of patients with neurological death'}, {'measure': 'Morbidity Rate', 'timeFrame': '1 year', 'description': 'Percentage of patients with major ipsilateral stroke'}], 'secondaryOutcomes': [{'measure': 'modified Rankin Score', 'timeFrame': '1 year', 'description': 'worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death)'}, {'measure': 'Complete aneurysm occlusion rate', 'timeFrame': '1 year', 'description': 'Measured by the Raymond Scale'}, {'measure': 'Retreatment Rate', 'timeFrame': '1 year', 'description': 'Rate and description of aneurysm retreated or planned for retreatment'}, {'measure': 'Patient description', 'timeFrame': '1 year', 'description': 'Description of the population of patients treated with FRED and FRED JR in France'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aneurysm', 'endovascular', 'flow-diverter'], 'conditions': ['Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': 'A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms', 'detailedDescription': 'Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.\n\nSample Size: 138 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with an intracranial aneurysm treated with the FRED or FRED JR Device', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR\n* Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04315168', 'briefTitle': 'FRED and FRED JR Devices for Intracranial Aneurysm Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Microvention-Terumo, Inc.'}, 'officialTitle': 'Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment', 'orgStudyIdInfo': {'id': 'FRED-EPI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FRED and FRED JR', 'type': 'DEVICE', 'otherNames': ['Flow Re-Direction Endoluminal Device'], 'description': 'Intracranial aneurysm treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Laurent Pierot, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Maison Blanche, Reims, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Microvention-Terumo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}