Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

NCT ID: NCT04057183

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Carotid Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Carotid Stenotic Scan

Noninvasive determination of presence or absence of carotid artery stenosis

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CSS

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phillip J Bendick

INDUSTRY

Sponsor Role lead

Responsible Party

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Phillip J Bendick

Study Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Michigan Vascular Center

Flint, Michigan, United States

Site Status NOT_YET_RECRUITING

Wake Forest Medical Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Phillip J Bendick, PhD

Role: CONTACT

2483960314

Tony Robinson

Role: CONTACT

8105778555

Facility Contacts

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Mark Mattos, MD

Role: primary

810-732-1620

Aarti Sarwal, MD

Role: primary

336-716-3961

Other Identifiers

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CVRMed

Identifier Type: -

Identifier Source: org_study_id

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