Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT03464851
Status:
TERMINATED
Last Update Posted:
2020-05-01
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-30', 'size': 714378, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-02T15:32', 'hasProtocol': True}, {'date': '2018-02-21', 'size': 344483, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-03-02T16:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low enrollment due to inclusion/exclusion criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of CSS readings to conventional carotid artery duplex ultrasound', 'timeFrame': 'Baseline', 'description': 'Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis'}], 'secondaryOutcomes': [{'measure': 'Reproducibility of the CSS measurement', 'timeFrame': 'Baseline', 'description': 'Each CSS measurement will be repeated and the Intraclass Correlation Coefficient (ICC) will be calculated. The ICC in an index of the reliability of measurements from the same operator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carotid artery stenosis', 'plaque', 'carotid duplex', 'ultrasound', 'fibromsucular dysplasia', 'carotid atherosclerosis'], 'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.', 'detailedDescription': 'Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.\n\nThis study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing.\n\nSubjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound.\n\nWithin 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consistent of adult patients (\\> 18 years) presenting to the Cleveland Clinic Non-Invasive Vascular Laboratory for a scheduled carotid duplex ultrasound to evaluate for carotid artery disease or in follow-up of known ICA stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients age \\> 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.\n* Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV \\> 125 cm/sec) or occlusion of one or both ICAs\n* Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.\n\nExclusion Criteria:\n\n* Age \\< 18 years.\n* Hospitalized inpatients.\n* Inability to provide informed consent.\n* Prior history of carotid endarterectomy or carotid artery stent.\n* Prior neck surgery\n* Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.'}, 'identificationModule': {'nctId': 'NCT03464851', 'briefTitle': 'Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis', 'orgStudyIdInfo': {'id': 'IRB 18-126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unknown/Normal/Mild Disease', 'description': 'No prior carotid duplex study or known normal or mild disease in the ICAs (PSV \\<= 125 cm/sec)', 'interventionNames': ['Diagnostic Test: Carotid Stenotic Scan (CSS)']}, {'label': 'Known moderate or severe ICA Stenosis (PSV>125 cm/sec)', 'interventionNames': ['Diagnostic Test: Carotid Stenotic Scan (CSS)']}, {'label': 'Known ICA Fibromuscular Dysplasia', 'interventionNames': ['Diagnostic Test: Carotid Stenotic Scan (CSS)']}], 'interventions': [{'name': 'Carotid Stenotic Scan (CSS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Placement of the CSS instrument on the carotid arteries to measure degree of stenosis\n\nof the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.', 'armGroupLabels': ['Known ICA Fibromuscular Dysplasia', 'Known moderate or severe ICA Stenosis (PSV>125 cm/sec)', 'Unknown/Normal/Mild Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Imad Bagh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'CVR Global, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Imad Bagh, M. D.', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}