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

Completed

• Conditions: Peripheral Arterial Disease; Diabetes Mellitus

• Registration Number: NCT06436001
• Lead Sponsor: Dakota Vascular

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-30
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	data collected from March 2023 to March 2024	Comparing ABI and BVE findings to FLAD
Accuracy	data collected from March 2023 to March 2024	Comparing ABI and BVE findings to FLAD
Specificity	data collected from March 2023 to March 2024	Comparing ABI and BVE findings to FLAD
Cohen's Kappa coefficient	data collected from March 2023 to March 2024	Comparing ABI and BVE findings to FLAD

Trial Locations

Locations (1)

Dakota Vascular; 🇺🇸 Sioux Falls, South Dakota, United States