Pressure and flow measurements during peripheral artery procedures
Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | University Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Trial ID | NCT07052435 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pátrai
- University Hospital of Patras — Pátrai, Greece (Recruiting)
Study contacts
- Study coordinator: Konstantinos Katsanos, MSc, MD, PhD, EBIR
- Email: katsanos@med.upatras.gr
- Phone: +302613603218
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.