NCT07052435 Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions
| NCT ID | NCT07052435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Konstantinos Katsanos |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-09-01 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) have been originally developed for physiological assessment of coronary artery disease and may hold potential in the management of Peripheral Arterial Disease (PAD) as well. By adapting pressure and flow measurements for the peripheral arteries, clinicians could objectively evaluate stenosis severity, guiding treatment decisions and optimizing outcomes. The aim of this study is to evaluate the diagnostic performance of FFR and vascular Flow Reserve (VFR, aka CFR) for detection of functionally significant peripheral arterial disease and to derive appropriate cut-off values for the prediction of successful immediate and long-term clinical outcomes.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07052435 clinical trial?
This trial is open to participants of all sexes, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052435 currently recruiting?
Yes, NCT07052435 is actively recruiting participants. Contact the research team at katsanos@med.upatras.gr for enrollment information.
Where is the NCT07052435 trial being conducted?
This trial is being conducted at Pátrai, Greece.
Who is sponsoring the NCT07052435 clinical trial?
NCT07052435 is sponsored by Dr. Konstantinos Katsanos. The trial plans to enroll 100 participants.