Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516315
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QFR
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 QFR22 software
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 QFR22 software
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 13 to 15 of all LEA
The global burden of LEAD is considerable In 2010 the years of life lost due to LEAD were estimated at 317 151 and 37 years per 100000 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 TomographyOCT 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 procedures 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 QFR22 software
2 Clinical variables
Age
Sex
HeightWeight
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 22 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 dQFRds
The global burden of LEAD is considerable In 2010 the years of life lost due to LEAD were estimated at 317 151 and 37 years per 100000 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 TomographyOCT 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 procedures 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 QFR22 software
2 Clinical variables
Age
Sex
HeightWeight
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 22 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 dQFRds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None