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

Lower Extremity Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689190
• Other study ID #: ICBE-S-000115
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: Iris Verel, PhD
• Phone: 650899680
• Email: iris.verel[@]philips.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Arterial Disease

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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