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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 13, 2019
First Posted Date August 15, 2019
Last Update Posted Date August 16, 2019
Actual Study Start Date July 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04057183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan
Official Title Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).

Condition Carotid Stenosis
Intervention Diagnostic Test: Carotid Stenotic Scan
Noninvasive determination of presence or absence of carotid artery stenosis
Other Name: CSS
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 13, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Phillip J Bendick, PhD 2483960314 pbeninnc@gmail.com
Contact: Tony Robinson 8105778555 tonyrobinson@cvrmed.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04057183
Other Study ID Numbers CVRMed
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will not be shared; only group data will be used.
Responsible Party Phillip J Bendick, CVR Medical
Study Sponsor Phillip J Bendick
Collaborators Not Provided
Investigators Not Provided
PRS Account CVR Medical
Verification Date August 2019