Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
Launched by DAKOTA VASCULAR · May 24, 2024
Trial Information
Current as of February 08, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sioux Falls, South Dakota, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0