Trial Outcomes & Findings for Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease (NCT NCT05073510)

NCT ID: NCT05073510

Last Updated: 2024-12-27

Results Overview

Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of the arterial duplex. Significant PAD is established with Duplex ultrasound when peak systolic velocity ratio (PSVR) is greater than 3 for any one level, or, if patients have multi-level disease, PSVR ≥ 2 at more than one level (i.e. sfa, pop)

• Recruitment status: COMPLETED
• Target enrollment: 187 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	BlueDop Vascular Expert (BVE) PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)
Overall Study STARTED	187
Overall Study COMPLETED	186
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	BlueDop Vascular Expert (BVE) n=187 Participants PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)
Age, Continuous	68.24 years STANDARD_DEVIATION 12.69 • n=187 Participants
Sex: Female, Male Female	64 Participants n=187 Participants
Sex: Female, Male Male	123 Participants n=187 Participants
Region of Enrollment Spain	187 participants n=187 Participants

PRIMARY outcome

Timeframe: 1 day

Population: ElP

Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of the arterial duplex.

Significant PAD is established with Duplex ultrasound when peak systolic velocity ratio (PSVR) is greater than 3 for any one level, or, if patients have multi-level disease, PSVR ≥ 2 at more than one level (i.e. sfa, pop)

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=331 Limbs PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex PAD assessment with Duplex	BVE-01 PAD assessment with BVE-01	ABPI Automated Measure PAD assessment with ABPI Automated measure
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex True Positives	62 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex False Positives	14 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex True Negatives	212 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and Arterial Duplex False Negatives	43 Limbs	—	—	—

SECONDARY outcome

Timeframe: 1 day

Population: ElP

Evaluation of clinical equivalence through a binary result (either presence or absence of significant PAD) in BVE compared to a binary summary of ABPI.

Significant PAD is established when ABPI index is <0.8.

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=326 Limbs PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex PAD assessment with Duplex	BVE-01 PAD assessment with BVE-01	ABPI Automated Measure PAD assessment with ABPI Automated measure
Determination of Presence or Absence of Significant PAD With BVE and ABPI True Positives	62 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and ABPI False Positives	11 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and ABPI True Negatives	202 Limbs	—	—	—
Determination of Presence or Absence of Significant PAD With BVE and ABPI False Negatives	51 Limbs	—	—	—

SECONDARY outcome

Timeframe: 1 day

Evaluation of BVE safety through the assessment of the risk and occurrence rates of AEs and SAEs

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=187 Participants PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex PAD assessment with Duplex	BVE-01 PAD assessment with BVE-01	ABPI Automated Measure PAD assessment with ABPI Automated measure
Number and Risk-classification of Adverse Events (AEs) and Serious Adverse Events (SAEs)	0 adverse events	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

Comparison of the time to perform a vascular assessment using arterial duplex, BVE, and ABPI (when available).

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=187 Participants PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex n=187 Participants PAD assessment with Duplex	BVE-01 n=187 Participants PAD assessment with BVE-01	ABPI Automated Measure n=187 Participants PAD assessment with ABPI Automated measure
Time Spent for Arterial Duplex, BVE and ABPI Vascular Assessment	11.36 minutes Standard Deviation 6.14	16.90 minutes Standard Deviation 6.57	15.21 minutes Standard Deviation 11.24	11.39 minutes Standard Deviation 3.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

Evaluation of clinical equivalence of BVE testing performed by staff specifically trained on BVE who are not vascular technologists/specialists compared to BVE testing performed by vascular technologists/specialists.

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=90 Limbs PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex PAD assessment with Duplex	BVE-01 PAD assessment with BVE-01	ABPI Automated Measure PAD assessment with ABPI Automated measure
Determination of Presence or Absence of Significant PAD With BVE by Vascular and Non-vascular Experts	0.8798 Proportion of cases with agreement	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

Population: This outcome was analyzed in the Enrollment population, not in the Eligible Population. The Eligible Population comprises the subset of enrolled patients who have at least one valid determination of PAD with both devices, and a limb without a valid PAD determination is considered analyzed if the other limb has a valid PAD determination. In the Enrollment Population we can find patients without any valid determination of PAD with BVE.

Number of patients and/or limbs that could not be assessed by BVE.

Outcome measures

Measure	BlueDop Vascular Expert (BVE) n=353 Limbs PAD assessment with BVE BVE: Participants will undergo BVE evaluation for assessing Peripheral Arterial Disease (PAD)	Duplex PAD assessment with Duplex	BVE-01 PAD assessment with BVE-01	ABPI Automated Measure PAD assessment with ABPI Automated measure
BVE Non-diagnostic Rate	74 Limbs	—	—	—

Adverse Events

BlueDop Vascular Expert (BVE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patrick Kelly

BlueDop Medical, Ltd.

Phone: +1 605 521 9831

Email: patrick@bluedopmedical.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee The results and data obtained in the Clinical Trial shall be the exclusive property of the Sponsor, who reserves the right to use the results of this Trial to submit them to the authorities of any country.
• Publication restrictions are in place

Restriction type: OTHER