Pressure (Fractional Flow Reserve) and Flow (Vascular Flow Reserve) Measurements During Peripheral Arterial Interventions

NCT07052435 | Recruiting

• 1 other identifier: 422
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia (CLI)

Keywords

fractional flow reserve; coronary flow reserve; vascular flow reserve

Outcome Measures

Primary Outcomes (1)

• TLF (Target lesion failure)

  TLF (Target lesion failure) is defined as the composite of clinically driven TLR (Target lesion revascularization), acute limb ischemia or vascular amputation related to the target vessel. Target lesion is the segment where intervention was performed, and the length of the target lesion is inclusive of the arterial segment treated. Target vessel is the major native femoropopliteal axis or bypass graft containing the target lesion.

  24 months

Secondary Outcomes (2)

• MALE (major adverse limb events)

  24 months

• MACE (major adverse cardiovascular events)

  24 months

Study Arms (1)

PAD

Infrainguinal arterial occlusive disease presenting with intermittent claudication or critical limb ischemia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering with symptoms of peripheral arterial disease (intermittent claudication or critical limb ischemia) and opting for endovascular treatment of infrainguinal arterial occlusive disease documented by Duplex ultrasound or cross-sectional imaging.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Konstantinos Katsanos: lead
• Medlytic Labs: collaborator
• Attikon Hospital: collaborator

Study Sites (1)

University Hospital of Patras

Pátrai, Greece

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Konstantinos Katsanos, MSc, MD, PhD, EBIR

CONTACT

+302613603218; katsanos@med.upatras.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)