Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-03-31 @ 4:22 AM
Study NCT ID:
NCT02037932
Status:
WITHDRAWN
Last Update Posted:
2015-11-06
First Post:
2014-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneurysm recurrence rate', 'timeFrame': '3-9 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Occlusion Rate', 'timeFrame': 'At immediate post-procedure (Day 1) and 3-9 month follow-up', 'description': 'Angiographic occlusion of the aneurysm will be adjudicated using immediate post-procedure and 3-9 month follow-up angiography.'}, {'measure': 'Number of coils used', 'timeFrame': 'At end of study procedure (Day 1)'}, {'measure': 'Total coil length used', 'timeFrame': 'At immediate post-procedure (Day 1)'}, {'measure': 'Aneurysm re-treatment rate', 'timeFrame': '3-9 month follow-up'}, {'measure': 'Aneurysm Bleed and Re-bleed Rate', 'timeFrame': '3-9 month follow-up', 'description': 'Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.'}, {'measure': 'Time of fluoroscopic exposure', 'timeFrame': 'At immediate post-procedure (Day 1)', 'description': 'Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.'}, {'measure': 'Modified Rankin Score', 'timeFrame': 'At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up', 'description': 'Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.'}, {'measure': 'Device-related serious adverse events', 'timeFrame': 'From the study procedure (Day 1) until 3-9 month follow up', 'description': 'Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aneurysm', 'Brain Aneurysm'], 'conditions': ['Intracranial Aneurysms', 'Aneurysm', 'Brain Aneurysm']}, 'descriptionModule': {'briefSummary': 'The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.', 'detailedDescription': 'This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is 18-80 years of age.\n* Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.\n* Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.\n* Patient has a Hunt and Hess Score of 3 or less.\n* Patient has a premorbid mRS of 3 or less.\n* Patient or patient's legally authorized representative has provided written informed consent.\n* Patient is willing to and can comply with study follow-up requirements.\n\nExclusion Criteria:\n\n* Inability to obtain informed consent.\n* Patient is \\<18 or \\>80 years of age.\n* Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.\n* Aneurysm that was treated previously with stent-assisted coiling.\n* Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.\n* Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.\n* Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.\n* Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).\n* Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).\n* Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)\n* Patients with a life expectancy of ≤ 9 months."}, 'identificationModule': {'nctId': 'NCT02037932', 'acronym': 'GELATIN', 'briefTitle': 'Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry', 'orgStudyIdInfo': {'id': '00021229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balloon Assisted Coiling', 'description': 'Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.', 'interventionNames': ['Device: Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.']}], 'interventions': [{'name': 'Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.', 'type': 'DEVICE', 'otherNames': ['MicroVention hydrogel coils', 'MicroVention Scepter C', 'MicroVention Scepter XC'], 'description': 'Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.', 'armGroupLabels': ['Balloon Assisted Coiling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Osama O Zaidat, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Microvention-Terumo, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}