Pressure and flow measurements during peripheral artery procedures
Official title: Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
Run by University Hospital of Patras · NCT07052435 · Data updated 2026-11-12
This will try pressure (FFR) and flow (VFR) measurements during procedures to see if they help people with peripheral artery disease or critical limb ischemia get the right treatment and better outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT07052435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with symptomatic peripheral arterial disease—intermittent claudication or critical limb ischemia—and documented femoropopliteal steno-occlusive lesions who can consent to percutaneous endovascular treatment are the ideal candidates.
✕Probably not a fit
Patients with aortoiliac occlusive disease, acute limb ischemia, aneurysmal infrainguinal disease, or those who cannot undergo endovascular procedures are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will measure fractional flow reserve (FFR) and vascular flow reserve (VFR) during endovascular procedures in patients with symptomatic femoropopliteal steno-occlusive disease. Pressure-sensitive guidewires and flow measurements will be recorded before and after angioplasty to generate physiological indices and derive optimal cut-off values. Those physiological results will be correlated with immediate technical success and longer-term clinical outcomes such as symptom improvement and limb salvage. Patients with aortoiliac occlusion, acute limb ischemia, aneurysmal infrainguinal disease, or contraindications to endovascular treatment will be excluded.
Why it matters
Potential benefit: If successful, clinicians could use pressure and flow measurements to more accurately identify functionally important peripheral blockages and better target treatments, potentially improving symptom relief and limb outcomes.
How similar studies have gone: The method is adapted from well-established coronary FFR/CFR techniques that are proven in heart disease, but peripheral application is exploratory with limited pilot data to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Symtpomatic peripheral arterial disease. Intermittent claudication or critical limb ischemia. Documented steno-occlusive disease of the femoropopliteal segment by imaging. Provision of informed consent form. Exclusion Criteria: Aortoiliac occlusive disease. Acute limb ischemia. Aneurysmal infrainguinal disease. General contra-indications to percutaneous ballon angioplasty and/or other endovascular procedures like dementia or bleeding diathesis.
Where it's running
-
University Hospital of Patras
Pátrai, Greece Recruiting
Study contacts
- Study coordinator: Konstantinos Katsanos, MSc, MD, PhD, EBIR
- Email: katsanos@med.upatras.gr
- Phone: +302613603218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.