Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436001
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
Sponsor:
Dakota Vascular
Organization:
Dakota Vascular
Study Overview
Official Title:
Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIRBI Link CR00555039 | OTHER | Advarra IRB | None |