Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Venous Distension in Patients With Aneurysmatic Arterial Disease

NCT02867501

Aortic Aneurysm, Abdominal Popliteal Artery Aneurysm Peripheral Arterial Occlusive Disease +3 more

COMPLETED

AngioDefender Versus Brachial Artery Ultrasound Imaging

NCT02468336

Cardiovascular Diseases

COMPLETED NA

EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

NCT01224600

Peripheral Arterial Disease Carotid Stenosis Abdominal Aortic Aneurysm

COMPLETED

Screening and Access to Health Care for Vascular Disease

NCT01889485

Aortic Aneurysm, Abdominal Carotid Stenosis Peripheral Arterial Disease

COMPLETED

Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)

NCT03989011

Abdominal Aortic Aneurysm Cardiovascular Events

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.

Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BlueDop Vascular Expert

BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex

No interventions assigned to this group

Ankle Brachial Index

ABI assessment verses Full Leg Arterial Duplex

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.

Exclusion Criteria

* Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes