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

NCT ID: NCT05689190

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Extremity Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients

Duplex ultrasound, angiogram, PTA intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carla SP van Rijswijk

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kirsten Huntjens

Role: CONTACT

639839645 ext. +31

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Principal Investigator

Role: primary

Bianca J. de Vreugd

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICBE-S-000115

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.