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

May 8, 2026 updated by: Philips Clinical & Medical Affairs Global
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 30 patients that are referred to the Vascular Surgery outpatient clinic (department of Vascular Surgery) with PAD and an indication for a percutaneous transluminal angioplasty.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients
Duplex ultrasound, angiogram, PTA intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
performed during a regular PTA intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Leiden University Medical Center

Investigators

  • Principal Investigator: Carla SP van Rijswijk, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Actual)

February 25, 2026

Study Completion (Actual)

February 25, 2026

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICBE-S-000115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Extremity Arterial Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe