Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02122133
Status:
TERMINATED
Last Update Posted:
2019-04-12
First Post:
2014-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Business decision to focus on other studies. No safety concern.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].', 'timeFrame': 'At immediate post-procedure', 'description': 'Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.'}, {'measure': '2. Procedural serious adverse events', 'timeFrame': 'Procedural serious adverse events up until 3 days or discharge, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IC aneurysms, coil embolization, PC 400, radiation exposure,'], 'conditions': ['Intracranial Aneurysms']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.\n* Patients treated with conventional coils should be treated per their IFU.\n* Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.\n\nExclusion Criteria:\n\n* Pre-planned use of multiple coil systems and/or flow diverters.'}, 'identificationModule': {'nctId': 'NCT02122133', 'acronym': 'CARE', 'briefTitle': 'CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': 'CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400', 'orgStudyIdInfo': {'id': 'CLP 7495'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PC 400', 'description': 'Patients treated with the PC 400 according to the IFU', 'interventionNames': ['Device: PC 400']}, {'label': 'Conventional Embolic Coils', 'description': 'These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms.', 'interventionNames': ['Device: PC 400']}], 'interventions': [{'name': 'PC 400', 'type': 'DEVICE', 'armGroupLabels': ['Conventional Embolic Coils', 'PC 400']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital Medical Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Abhineet Chowdhary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}