Actively Recruiting
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.
Led by Fondation Hôpital Saint-Joseph · Updated on 2024-07-23
35
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
F
Fondation Hôpital Saint-Joseph
Lead Sponsor
M
Medis Medical Imaging Systems B.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with symptomatic Rutherford stage 2 to 6 AOMI with an indication for endovascular revascularization
- Patient with a simple lesion (TASC A) and short stenosis of the superficial femoral artery
- Patient affiliated to a health insurance system
- French-speaking patient
- Patient with free, informed and express oral consent
You will not qualify if you...
- Renal failure patients with GFR < 30 ml/min
- Patient deprived of liberty
- Patients under court protection
- Pregnant or breast-feeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand
Paris, Île-de-France Region, France, 750014
Actively Recruiting
Research Team
M
Michèle LOHORE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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