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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand
RECRUITING
Paris
Contact Information
Primary
Michèle LOHORE
crc@ghpsj.fr
+ 331 44127883
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2025-05-24
Participants
Target number of participants: 35
Treatments
Experimental: qfr
Patients with indication for endovascular revascularization of a short stenosis of the superficial femoral artery (TASC A, Rutherford stage 2 to 6) :~* Preoperative ultrasound, performed the day before or the day of surgery~* Intraoperative angiography performed immediately prior to revascularization (routine care procedure whose duration is extended by research)~* Quantitative analysis of angiography images will be performed post-procedure using Medis QFR®2.2 software.
Sponsors
Collaborators: Medis Medical Imaging Systems B.V.
Leads: Fondation Hôpital Saint-Joseph

This content was sourced from clinicaltrials.gov