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

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limbs Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Preoperative ultrasound examination.; Procedure: Peroperatoire angiography procedure and QFR analysis

Detailed Description

Approximately 202 million people are affected with lower extremity artery disease (LEAD) worldwide, of whom almost 40 million are living in Europe. LEAD usually appears after the age of 50 years, with an exponential increase after the age of 65. This rate reaches around 20% by the age of 80. In most studies, the proportion of symptomatic LEAD is 1:3 to 1:5 of all LEA.

The global burden of LEAD is considerable. In 2010, the years of life lost due to LEAD were estimated at 31.7, 15.1, and 3.7 years per 100,000 inhabitants in Western, Central, and Eastern Europe, respectively.

During the two last decade, indications of endovascular approach of femoropopliteal lesions have dramatically increased, to become the gold standard with a first endo strategy approach. In 2000, endovascular treatment was recommended for stenosis ≤ 5cm or occlusions ≤ 3cm. Today, the guidelines suggest endo approach for lesion until 25 cm In 2019, in France, 50 000 patients underwent an endovascular femoral popliteal revascularization, and drug eluting devices (Stents or Balloons). According to the Excellence in Peripheral Artery Disease Registry, early stent occlusion is about 5% during the 6 first months after procedure. Success rate of endovascular procedure is high, but many thrombosis are due to incomplete endovascular treatment, leading to early re-occlusion. Usually, quality and success assessment are made by the operator, based on images provided by a single plan angiography. Vascular surgeons face a lack of devices helping us to appreciate the quality of our revascularization per procedure. Endovascular ultrasounds (IVUS) or Optical Coherence Tomography(OCT) are not reimbursed in many countries. These devices are quite expensive and, like the FFR, require the introduction of dedicated devices into the arteries, thus increasing procedure's duration.

Similar situation can be seen in patients undergoing coronary percutaneous coronary intervention (PCI), current evidence indicates post-PCI suboptimal results. However, the combination of quantitative vessel analysis (QVA) with angiography-derived fractional flow reserve (FFR) assessment has shown promising improvements in PCI outcomes. A notable non-invasive solution for angiography derived FFR is Quantitative Flow Ratio (QFR), which includes quantitative vessel analysis (QVA) reporting significant enhancement in revascularization therapy.

Extending its potential benefits, QFR emerges as a non-invasive and cost-effective solution to improve revascularization outcomes for lower extremities.

MAIN OBJECTIVE The main objective of this study is to explore the feasibility of using QFR as a tool to predict the success rate of endovascular revascularization in patients with superficial artery disease.

METHODS:

1. Study design and Population 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 (TASC A, Rutherford stage 2 to 6). 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.

2. Clinical variables:

   • Age
   • Sex
   • Height/Weight
   • Previous medical history
   • Rutherford classification
   • TASC lesion (only for sfa)
   • Procedure: - Type of treatment
   • Stents (type, length, diameter, number)
   • Amount of contrast
   • Xray duration
   • Xray Dose (Gy)
   • Technical success
   • Outcomes: 30 days patency
3. Angiography procedure and acquisition protocol Selective PCI will be performed using standard catheterization according to European society of Cardiology guidelines for lower extremity artery disease. At least two projections angles separated at least 25 degrees were acquired for the optimal view of the lesions. Details of the acquisition protocol are described in appendix B.
4. QCA and QFR analysis The 3D QCA and QFR analysis will be performed using a research version of software package QFR 2.2. QFR allows to match two diagnostic angiographic projections and create a 3D reconstruction of the interrogated vessel. From this reconstruction the following parameters will be derived: lesions length, QFR, delta(△) QFR, % diameter of stenosis, minimum lumen diameter, residual QFR, QFR pullback curve and derivative of QFR pullback curve (dQFR/ds).

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michèle LOHORE; Phone Number: + 331 44127883; Email: crc@ghpsj.fr

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 750014
      • Recruiting
      • Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand
      • Contact: MICHELE LOHORE; Email: crc@ghpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of stenosis	Percentage of stenosis measured by preoperative ultrasound, performed the day before or the day of surgery.	Day -1, Day 0
Occurrence of a Major Adverse Limb Event (MALE)	Occurrence of a Major Adverse Limb Event (MALE) at 1 month post-op (D30): Acute ischemia OR Major amputation OR Re-intervention on revascularized limb (excluding minor amputation).	Day 30
Re-hospitalization	Re-hospitalization for any reason at 1 month post-procedure (D30).	Day 30
Revascularization	Revascularization (endovascular or surgical) of the treated area (Target Lesion Revascularization (TLR)) defined by re-intervention on the target lesion, including 1 cm above and below the target lesion.	Day 30
Rutherford classification	Rutherford classification at 1 month post-op.	Day 30
Dosimetry and dose of contrast medium	Dosimetry and dose of contrast medium injected during the procedure (D0).	Day 0
Procedure envisaged by surgeon	Procedure envisaged by surgeon 1 and procedure envisaged by surgeon 2 after reading the QFR.	Day 0
Creatinine levels and glomerular filtration rate	Preoperative (D0) and postoperative (D5 and D30) creatinine levels and glomerular filtration rate.	Day 5, Day 30

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph
• Collaborators: Medis Medical Imaging Systems B.V.
• Investigators: Principal Investigator: Maxime RAUX, Principal investigator, Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): April 24, 2025
• Study Completion (Estimated): May 24, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: endovascular procedure; Lower Limbs Peripheral Arterial Disease; angiographic Quantitative Flow Ratio
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 684_QFR; 2024-A00022-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No