Clinical Trial

Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.

Study acronym: QFR
Unknown
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Record status
This record was last updated July 23, 2024 (before its estimated April 24, 2025 completion). Its status may not reflect the trial's current state.
Summary
The main objective of this study is to explore the feasibility of using the angiographic Quantitative Flow Ratio (QFR) as a tool to predict the success rate of endovascular revascularization in patients with superficial artery disease. This is a prospective feasibility study. We aim to include 35 patients with indication for endovascular revascularization of a short stenosis of the superficial femoral artery. Intraoperative angiography will be performed immediately prior to revascularization. Quantitative analysis of angiography images will be performed post-procedure using Medis QFR®2.2 software.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06516315
Lead Sponsor Fondation Hôpital Saint-Joseph
Collaborators: Medis Medical Imaging Systems B.V.
Conditions Lower Limbs Peripheral Arterial Disease
Enrollment 35 participants
Start Date 2024-04-29
Primary Completion 2025-04-24 (estimated)
Study Completion 2025-05-24 (estimated)
Updated on ClinicalTrials.gov 2024-07-23