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Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan (CSS)

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ClinicalTrials.gov Identifier: NCT04057183
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Phillip J Bendick, CVR Medical

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 carotid duplex ultrasound study.

Condition or disease Intervention/treatment
Carotid Stenosis Diagnostic Test: Carotid Stenotic Scan

Detailed Description:

Currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation 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. this test is not considered suitable for screening for disease. 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 Medical. The CSS instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of 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 either before or after the carotid duplex ultrasound.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans


Intervention Details:
  • Diagnostic Test: Carotid Stenotic Scan
    Noninvasive determination of presence or absence of carotid artery stenosis
    Other Name: CSS


Primary Outcome Measures :
  1. Comparison of CSS result to carotid artery duplex ultrasound examination [ Time Frame: CSS and duplex ultrasound done within one week of each other ]
    Percent agreement and negative predictive value of CSS compared to duplex ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion criteria identify an "at-risk" population with unknown carotid artery status. The literature indicates that patients who meet the criteria have a prevalence of significant carotid artery stenosis (>50%) of 7-10%. Current estimates are that 3 million adults in the United States have this degree of carotid artery disease with an annual stroke risk of 5-10%.

Exclusion criteria are in place to identify patients in whom the status of the carotid arteries is already likely known (prior CEA or stent), have significant heart disease which will impact flow hemodynamics and create false negative or positive studies (CHF, aortic stenosis), or have excessive subcutaneous neck tissue that will attenuate and mask the CSS signal (elevated BMI).

Criteria

Inclusion Criteria:

  • Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following:
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Tobacco usage - Current or past
  • Known CAD/PAD
  • Family history of early onset of atherosclerotic disease

Exclusion Criteria:

  • Unable / unwilling to provide Informed Consent
  • Prior carotid endarterectomy or carotid artery stent
  • Aortic stenosis
  • Congestive heart failure
  • BMI > 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057183


Contacts
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Contact: Phillip J Bendick, PhD 2483960314 pbeninnc@gmail.com
Contact: Tony Robinson 8105778555 tonyrobinson@cvrmed.com

Locations
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United States, Michigan
Michigan Vascular Center Not yet recruiting
Flint, Michigan, United States, 48507
Contact: Mark Mattos, MD    810-732-1620    markmattos2011@gmail.com   
United States, North Carolina
Wake Forest Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Aarti Sarwal, MD    336-716-3961    asarwal@wakehealth.edu   
Sponsors and Collaborators
Phillip J Bendick

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Responsible Party: Phillip J Bendick, Study Coordinator, CVR Medical
ClinicalTrials.gov Identifier: NCT04057183     History of Changes
Other Study ID Numbers: CVRMed
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared; only group data will be used.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Phillip J Bendick, CVR Medical:
Carotid
Stenosis
Noninvasive
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Arterial Occlusive Diseases
Constriction, Pathologic
Pathological Conditions, Anatomical
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases