Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-05 @ 1:08 AM
Study NCT ID:
NCT00703794
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2008-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Researching AXIUM Coiling Experience and Recanalization (RACER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2008-06-23', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Occlusion', 'timeFrame': 'Defined in protocol'}], 'secondaryOutcomes': [{'measure': 'Morbidity/Mortality', 'timeFrame': 'Defined in protocol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ev3 Neurovascular', 'aneurysms', 'cerebrovascular', 'endovascular', 'neurovascular therapies', 'RACER', 'AXIUM', 'The AXIUM Progressive Coil System', 'ev3', 'MTI', 'Micro Therapeutics', 'FX detachable coil system', 'K060747', 'brain diseases'], 'conditions': ['Aneurysms', 'Vascular Diseases', 'Cerebrovascular Disorders', 'Intracranial Arterial Diseases']}, 'referencesModule': {'references': [{'pmid': '8315465', 'type': 'BACKGROUND', 'citation': 'Casasco AE, Aymard A, Gobin YP, Houdart E, Rogopoulos A, George B, Hodes JE, Cophignon J, Merland JJ. Selective endovascular treatment of 71 intracranial aneurysms with platinum coils. J Neurosurg. 1993 Jul;79(1):3-10. doi: 10.3171/jns.1993.79.1.0003.'}, {'pmid': '17698550', 'type': 'BACKGROUND', 'citation': 'Wakhloo AK, Gounis MJ, Sandhu JS, Akkawi N, Schenck AE, Linfante I. Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability, and midterm angiographic outcome. AJNR Am J Neuroradiol. 2007 Aug;28(7):1395-400. doi: 10.3174/ajnr.A0542.'}, {'pmid': '17322071', 'type': 'BACKGROUND', 'citation': 'Linfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. doi: 10.1161/01.STR.0000259824.10732.bb. Epub 2007 Feb 22.'}, {'pmid': '15206430', 'type': 'BACKGROUND', 'citation': 'Razack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. doi: 10.1097/00041327-200403000-00001. No abstract available.'}, {'pmid': '16575325', 'type': 'BACKGROUND', 'citation': 'Mericle RA, Reig AS, Burry MV, Eskioglu E, Firment CS, Santra S. Endovascular surgery for proximal posterior inferior cerebellar artery aneurysms: an analysis of Glasgow Outcome Score by Hunt-Hess grades. Neurosurgery. 2006 Apr;58(4):619-25; discussion 619-25. doi: 10.1227/01.NEU.0000204127.81249.28.'}, {'pmid': '11844258', 'type': 'BACKGROUND', 'citation': 'Thornton J, Debrun GM, Aletich VA, Bashir Q, Charbel FT, Ausman J. Follow-up angiography of intracranial aneurysms treated with endovascular placement of Guglielmi detachable coils. Neurosurgery. 2002 Feb;50(2):239-49; discussion 249-50. doi: 10.1097/00006123-200202000-00003.'}], 'seeAlsoLinks': [{'url': 'http://www.ev3.net', 'label': 'ev3 Inc.'}]}, 'descriptionModule': {'briefSummary': 'The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.\n\nThis Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form\n* Must be at least 18 years of age\n* Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable\n* Patient is willing to conduct follow-up visits\n\nExclusion Criteria:\n\n* Aneurysm was previously treated\n* Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures\n* Patient is participating in another clinical research Study\n* Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up\n* Female patient is pregnant or breast-feeding"}, 'identificationModule': {'nctId': 'NCT00703794', 'acronym': 'RACER', 'briefTitle': 'Researching AXIUM Coiling Experience and Recanalization (RACER)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Neurovascular Clinical Affairs'}, 'officialTitle': 'ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)', 'orgStudyIdInfo': {'id': 'ev3-FD1942-CR00045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AXIUM Coils', 'interventionNames': ['Device: The AXIUM Progressive Coil System']}], 'interventions': [{'name': 'The AXIUM Progressive Coil System', 'type': 'DEVICE', 'description': 'Embolization of aneurysm', 'armGroupLabels': ['AXIUM Coils']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Lac+Usc/Uscuh', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami - Jackson Memorial Hospital Systems', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Bayfront Medical Center', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Neurologic & Orthopedic Hospital of Chicago (NOHC)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Kaleida Health - Millard Fillmore', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Richland Health Memorial Hospital', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '05401-1473', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ajay K Wakhloo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Neurovascular Clinical Affairs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}