Clinical Trials Logo

Clinical Trial 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 carotid ultrasound study.


Clinical Trial 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 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.

This 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.

Subjects 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.

Within 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03464851
Study type Observational
Source The Cleveland Clinic
Contact
Status Terminated
Phase
Start date March 8, 2018
Completion date February 1, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931161 - Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1) Phase 4
Recruiting NCT03353103 - Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy Phase 2
Completed NCT03996148 - Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques Phase 4
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Completed NCT00318851 - Carotid Artery Stenting With Protection Registry Phase 3
Active, not recruiting NCT05293067 - Troponin In Carotid Revascularization
Completed NCT03133429 - Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation. N/A
Recruiting NCT01440036 - The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque N/A
Completed NCT00417963 - ViVEXX Carotid Revascularization Trial (VIVA) Phase 3
Completed NCT00177346 - A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection N/A
Recruiting NCT05574972 - Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis(Timing Trial) N/A
Recruiting NCT02476396 - Structural Stability of Carotid Plaque and Symptomatology
Completed NCT05451485 - VFI in Healthy Vessels
Recruiting NCT06033963 - Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy N/A
Not yet recruiting NCT02224209 - Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis Phase 4
Completed NCT02006095 - Neuroimaging Correlates of Memory Decline Following Carotid Interventions
Terminated NCT01236508 - Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease Phase 4
Recruiting NCT05126238 - A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction Phase 3
Recruiting NCT06170580 - Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging