Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05563051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kaneka Endovascular Embolization and Protection
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate Occlusion', 'timeFrame': '12 months', 'description': 'Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)'}], 'secondaryOutcomes': [{'measure': 'Complete Occlusion', 'timeFrame': '12 months', 'description': 'Complete occlusion at 1 year (Modified Raymond-Roy I)'}, {'measure': 'Packing Density', 'timeFrame': '12 months', 'description': 'Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume'}, {'measure': 'Modified Rankin Score', 'timeFrame': '12 months', 'description': 'Modified Rankin Score (Scale from 0-6), the lower the score the better - 0 No symptoms and 6 is dead.\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'}, {'measure': 'Retreatment', 'timeFrame': '12 months', 'description': 'Any retreatment of the aneurysm, surgically or interventional embolization'}, {'measure': 'Adverse events', 'timeFrame': '12 months', 'description': 'Device or procedure related adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['aneurysm', 'coil', 'i-ED COIL', 'embolization', 'neuro endovascular'], 'conditions': ['Aneurysm Cerebral']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure', 'detailedDescription': 'Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)\n\nStudy Duration\n\nAnticipated timeline for study:\n\nPatient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Target aneurysm of 4mm - 14mm in size\n* Ruptured or unruptured\n* Suitable for embolization with coils\n* May be treated with or without assist devices\n\nExclusion Criteria:\n\n* Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)\n* Pre-planned staged procedure of target aneurysm\n* mRS score 3 or more\n* Hunt Hess Score more than 3 for subjects with ruptured aneurysm\n* Evidence of active infection (e.g.,fever, temperature \\>38 degrees C and/or WBC \\>15,000)'}, 'identificationModule': {'nctId': 'NCT05563051', 'acronym': 'KEEP', 'briefTitle': 'Kaneka Endovascular Embolization and Protection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaneka Medical America LLC'}, 'officialTitle': 'Kaneka Endovascular Embolization and Protection', 'orgStudyIdInfo': {'id': 'KMA-IVRNV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interventional treatment', 'description': 'Open label', 'interventionNames': ['Device: i-ED COIL']}], 'interventions': [{'name': 'i-ED COIL', 'type': 'DEVICE', 'otherNames': ['Embolic coils', 'Embolization coils'], 'description': 'The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.', 'armGroupLabels': ['Interventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Health Care', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "SSM Health St. Anthony's Hospital", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Ajit Puri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}, {'name': 'Mohamed Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaneka Medical America LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}