Trials
Search / Trial NCT06436001

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

Launched by DAKOTA VASCULAR · May 24, 2024

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Trial Information

Current as of February 08, 2025

Completed

Keywords

Peripheral Arterial Disease Ankle Brachial Index Arterial Duplex Doppler Waveform

ClinConnect Summary

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 extr...

Gender

ALL

Eligibility criteria

  • 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.

About Dakota Vascular

Dakota Vascular is a leading clinical trial sponsor dedicated to advancing vascular health through innovative research and development. With a focus on enhancing patient outcomes, the organization specializes in designing and conducting clinical studies that evaluate cutting-edge medical devices and therapeutic interventions. Committed to rigorous scientific standards and patient safety, Dakota Vascular collaborates with healthcare professionals and regulatory bodies to ensure the integrity of its trials. Through its comprehensive approach, Dakota Vascular aims to contribute significantly to the field of vascular medicine, ultimately improving treatment options and quality of life for patients worldwide.

Locations

Sioux Falls, South Dakota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0