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

NCT06516315 | Recruiting

• 2 other identifiers: 684_QFR2024-A00022-45
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lower Limbs Peripheral Arterial Disease; endovascular procedure; angiographic Quantitative Flow Ratio

Outcome Measures

Primary Outcomes (1)

• Preoperative systolic velocity peak and intraoperative QFR

  Systolic velocity peak measured by preoperative ultrasound, performed the day before or the day of surgery, and QFR measured intraoperatively, immediately before the revascularization procedure.

  Day -1, Day 0

Secondary Outcomes (8)

• Percentage of stenosis

  Day -1, Day 0

• Occurrence of a Major Adverse Limb Event (MALE)

  Day 30

• Re-hospitalization

  Day 30

• Revascularization

  Day 30

• Rutherford classification

  Day 30

Study Arms (1)

qfr

EXPERIMENTAL

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.

Procedure: Preoperative ultrasound examination.; Procedure: Peroperatoire angiography procedure and QFR analysis

Interventions

Preoperative ultrasound examination. PROCEDURE

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

qfr

Peroperatoire angiography procedure and QFR analysis PROCEDURE

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.

qfr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Renal failure patients with GFR \< 30 ml/min
• Patient deprived of liberty
• Patients under court protection
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Medis Medical Imaging Systems B.V.: collaborator

Study Sites (1)

Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand

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

RECRUITING

Study Officials

• Maxime RAUX, Principal investigator

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michèle LOHORE

CONTACT

+ 331 44127883; crc@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective feasibility study

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 23, 2024
• Study Start: April 29, 2024
• Primary Completion: April 24, 2025
• Study Completion: May 24, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)