NCT05689190

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

January 9, 2023

Last Update Submit

May 8, 2026

Conditions

Lower Extremity Arterial Disease

Keywords

blood flow measurements

Outcome Measures

Primary Outcomes (1)

  • blood flow

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

    performed during a regular PTA intervention

Study Arms (1)

patients

Duplex ultrasound, angiogram, PTA intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

Location

Study Officials

  • Carla SP van Rijswijk

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 19, 2023

Study Start

April 25, 2023

Primary Completion

February 25, 2026

Study Completion

February 25, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)