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
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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie blood flow improvement in LEAD patients using 2D Duplex Ultrasound?
How does non-invasive flow measurement compare to standard angiography in LEAD treatment monitoring?
Which biomarkers correlate with improved perfusion outcomes in LEAD after endovascular intervention?
What are the potential adverse events associated with endovascular treatment in LEAD patients?
Are there combination therapies with endovascular approaches that enhance LEAD management outcomes?
Trial Locations
- Locations (1)
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Leiden University Medical Center🇳🇱Leiden, NetherlandsPrincipal InvestigatorContactc.s.p.van_rijswijk@lumc.nlBianca J. de VreugdContactJ.J.de_Vreugd@lumc.nl