Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-04 @ 4:50 PM
Study NCT ID:
NCT01754051
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2012-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Packing density with the number of coils implanted', 'timeFrame': 'During the procedure'}, {'measure': 'Time of fluoroscopic exposure', 'timeFrame': 'During the procedure'}, {'measure': 'Procedural device-related serious adverse events at immediate post-procedure', 'timeFrame': 'During the procedure'}, {'measure': 'Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale', 'timeFrame': 'At 1 year post-procedure'}], 'secondaryOutcomes': [{'measure': 'Acute occlusion of the aneurysm sac at immediate post-procedure', 'timeFrame': 'At immediate post-procedure'}, {'measure': 'Adverse events occurring during the procedure and in the 30±7 days following the treatment.', 'timeFrame': 'During and at 30 days post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Intracranial aneurysms \\>2mm, ruptured or unruptured\n\nExclusion Criteria:\n\n* Fusiform aneurysms\n* Dissecting aneurysms\n* Aneurysms associated with brain AVMs\n* Multiple aneurysms\n* Re-treated aneurysms\n* Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.'}, 'identificationModule': {'nctId': 'NCT01754051', 'acronym': 'VOLCAN', 'briefTitle': 'A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': 'VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System', 'orgStudyIdInfo': {'id': 'CLP 4818'}, 'secondaryIdInfos': [{'id': 'CLP 4818', 'type': 'OTHER', 'domain': 'Penumbra Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment by the PC 400 coils', 'description': 'Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use.', 'interventionNames': ['Device: PC 400 coils']}], 'interventions': [{'name': 'PC 400 coils', 'type': 'DEVICE', 'armGroupLabels': ['Treatment by the PC 400 coils']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Dr. Jérôme Berge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Pellegrin - Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}