Clinical Trials/NCT05689190

NCT05689190

Recruiting

N/A

Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)

Philips Clinical & Medical Affairs Global1 site in 1 country30 target enrollmentApril 25, 2023

ConditionsLower Extremity Arterial Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lower Extremity Arterial Disease
Sponsor: Philips Clinical & Medical Affairs Global
Enrollment: 30
Locations: 1
Primary Endpoint: blood flow
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

March 31, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Philips Clinical & Medical Affairs Global

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
•Age ≥18 years
•Superficial femoral artery (SFA) stenosis (\>70% occluded)
•Elective for a percutaneous transluminal angioplasty procedure
•Written informed consent

Exclusion Criteria

•Contraindications to angiography, such as severe renal insufficiency (eGFR\< 20)
•Non-correctable bleeding disorder.

Outcomes

Primary Outcomes

blood flow

Time Frame: performed during a regular PTA intervention

Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.

Study Sites (1)

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