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

NCT06516315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Lower Limbs Peripheral Arterial Disease

Interventions

PROCEDURE

Preoperative ultrasound examination.

Preoperative ultrasound examination performed the day before or the day of surgery.

PROCEDURE

Peroperatoire angiography procedure and QFR analysis

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.

Sponsors & Collaborators

  • Medis Medical Imaging Systems B.V.

    collaborator UNKNOWN

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Maxime RAUX, Principal investigator · Fondation Hôpital Saint-Joseph

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2025-04-24
Completion
2025-05-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516315 on ClinicalTrials.gov