Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

NCT03464851 | Terminated

• 1 other identifier: IRB 18-126
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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 ultrasound study.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosis; plaque; carotid duplex; ultrasound; fibromsucular dysplasia; carotid atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Comparison of CSS readings to conventional carotid artery duplex ultrasound

  Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis

  Baseline

Secondary Outcomes (1)

• Reproducibility of the CSS measurement

  Baseline

Study Arms (3)

Unknown/Normal/Mild Disease

No prior carotid duplex study or known normal or mild disease in the ICAs (PSV \<= 125 cm/sec)

Diagnostic Test: Carotid Stenotic Scan (CSS)

Known moderate or severe ICA Stenosis (PSV>125 cm/sec)

Diagnostic Test: Carotid Stenotic Scan (CSS)

Known ICA Fibromuscular Dysplasia

Diagnostic Test: Carotid Stenotic Scan (CSS)

Interventions

Carotid Stenotic Scan (CSS) DIAGNOSTIC_TEST

Placement of the CSS instrument on the carotid arteries to measure degree of stenosis of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.

Known ICA Fibromuscular Dysplasia; Known moderate or severe ICA Stenosis (PSV>125 cm/sec); Unknown/Normal/Mild Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consistent of adult patients (\> 18 years) presenting to the Cleveland Clinic Non-Invasive Vascular Laboratory for a scheduled carotid duplex ultrasound to evaluate for carotid artery disease or in follow-up of known ICA stenosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• CVR Global, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carotid Stenosis; Plaque, Amyloid; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Imad Bagh, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: March 8, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)