Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06516315

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand

Paris, Île-de-France Region, France, 750014

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here