Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 5:26 PM
Study NCT ID:
NCT01205633
Status:
SUSPENDED
Last Update Posted:
2012-09-18
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Registry for CCSVI Testing and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'whyStopped': '9/12/12 FDA stopped enrollment pending device exemption(IDE)application.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-15', 'studyFirstSubmitDate': '2010-09-17', 'studyFirstSubmitQcDate': '2010-09-17', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-Form 36 (SF36) Quality of Life Instrument', 'timeFrame': 'Baseline and at 1, 6 and 12 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neurodegenerative disease', 'neurovascular disease', 'fatigue', 'Hubbard Foundation', 'angioplasty'], 'conditions': ['CCSVI', 'Chronic Cerebrospinal Venous Insufficiency', 'Venous Malformations of CNS Draining Veins']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hubbardfoundation.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.", 'detailedDescription': 'more to follow'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nReferral by patients primary treating physician for suspected CCSVI\n\nExclusion Criteria:\n\nAbnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01205633', 'acronym': 'CCSVI', 'briefTitle': 'Multi-center Registry for CCSVI Testing and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hubbard Foundation'}, 'officialTitle': 'Multi-center Registry for CCSVI Testing and Treatment', 'orgStudyIdInfo': {'id': 'CCSVI Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CNS draining vein abnormalities', 'interventionNames': ['Procedure: venous angioplasty']}], 'interventions': [{'name': 'venous angioplasty', 'type': 'PROCEDURE', 'description': 'catheter venous angioplasty via femoral vein approach', 'armGroupLabels': ['CNS draining vein abnormalities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90241', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Vascular Access Center of Downey', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Radiology', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Vascular Access Care of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia endovascular Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Valley Endovascular Associates', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Interventional Radiology', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley Interventional Associates', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Vascular Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '14220', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Vascular Access Center of Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David R Hubbard, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hubbard Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hubbard Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}