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

Recruiting

• Conditions: Lower Extremity Arterial Disease

• Registration Number: NCT05689190
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Study Start: 2023-04-25
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands