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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05689190

Enrollment

Registered

2023-01-19

Start date

2023-04-25

Completion date

2026-02-25

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Arterial Disease

Keywords

blood flow measurements

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
blood flow	performed during a regular PTA intervention	Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORCarla SP van Rijswijk

Leiden University Medical Center

Outcome results