Status:
TERMINATED
Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
CVR Global, Inc.
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 caroti...
Detailed Description
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 subs...
Eligibility Criteria
Inclusion
- 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.
- 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
- Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.
Exclusion
- Age \< 18 years.
- Hospitalized inpatients.
- Inability to provide informed consent.
- Prior history of carotid endarterectomy or carotid artery stent.
- Prior neck surgery
- Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03464851
Start Date
March 8 2018
End Date
February 1 2020
Last Update
May 1 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195