Measuring blood flow in patients with lower extremity arterial disease
Non-invasive Flow Measurements in Patients with Lower Extremity Arterial Disease (LEAD)
This study is trying to see how well blood flows in patients with lower extremity arterial disease who are getting a specific treatment to improve their circulation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 1 site (Leiden) |
| Trial ID | NCT05689190 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with lower extremity arterial disease who are scheduled for endovascular treatment. It utilizes 2D Duplex Ultrasound to non-invasively measure blood flow and collects contrast data for offline processing. The aim is to gather detailed information on blood flow dynamics in patients undergoing percutaneous transluminal angioplasty. The study will help in understanding the effectiveness of the treatment and the condition of the arteries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with significant stenosis in the superficial femoral artery who are scheduled for angioplasty.
Not a fit: Patients with severe renal insufficiency or non-correctable bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of blood flow in patients with lower extremity arterial disease, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies using non-invasive blood flow measurement techniques have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
Study contacts
- Principal investigator: Carla SP van Rijswijk — Leiden University Medical Center
- Study coordinator: Kirsten Huntjens
- Email: kirsten.huntjens@philips.com
- Phone: 639839645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.