Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate (AIFITI)

Atherosclerosis can cause the arteries to narrow (stenosis) or clog (occlude), leading to reduced blood flow.

Arteriography or angiography is a radiological examination of the arteries which will make it possible to confirm and quantify the severity of the damage to the artery and which, in certain cases, can be directly treated by angioplasty with or without stenting (selective angioplasty).

Digital subtraction angiography (DSA), the reference technique, provides good image quality. The fluoroscopy used today during angioplasty procedures makes it possible to obtain images in real time and to guide the progression of the endovascular material in the arterial axis. Image fusion is an established technique for the endovascular treatment of aortic aneurysms. The feasibility of image fusion for the iliac arterial axes has already been assessed and is reproducible. However, there is no assessment of the irradiation rate in iliac angioplasty, using intraoperative image fusion, compared to standard angioplasty practices.

Study Overview

• Status: Recruiting
• Conditions: Irradiation Rate; Image, Body; Iliac Artery Disease
• Intervention / Treatment: Procedure: Standard Angioplasty; Procedure: Angioplasty with D images

Detailed Description

Atherosclerosis can cause the arteries to narrow (stenosis) or clog (occlude), leading to reduced blood flow. Iliac stenosis can be asymptomatic or symptomatic. Clinical manifestations are related to the degree of narrowing. The symptoms are in order of increasing severity: pain in the legs when walking (intermittent claudication), at rest, even foot or leg ulcers.

Arteriography or angiography is a radiological examination of the arteries requiring the injection of contrast product which will make it possible to confirm and quantify the severity of the damage to the artery and which, in certain cases, can be directly treated by angioplasty with or without stenting (selective angioplasty).

Digital subtraction angiography (DSA), the reference technique, provides good image quality. The fluoroscopy used today during angioplasty procedures makes it possible to obtain images in real time and to guide the progression of the endovascular material in the arterial axis. Image fusion is an established technique for the endovascular treatment of aortic aneurysms. The feasibility of image fusion for the iliac arterial axes has already been assessed and is reproducible. However, there is no assessment of the irradiation rate in iliac angioplasty, using intraoperative image fusion, compared to standard angioplasty practices.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JF ECTEN; Phone Number: 0683346567; Email: jf.oudet@ecten.eu
• Study Contact Backup: Name: MH BArba; Phone Number: 0664888704; Email: MH.Barba@ecten.eu

Study Locations

• France
  • Bretagne
    • Nantes, Bretagne, France, 44093
      • Recruiting
      • CHU de Nantes
      • Contact: Blandine Maurel, Dr
  • Normandy
    • Caen, Normandy, France, 14050
      • Recruiting
      • Saint Martin Private Hospital
      • Contact: Maximilien GIOVANNETTI, Dr; Phone Number: +336231433096; Email: maxgiov@hotmail.fr
      • Contact: Marie Barba; Phone Number: +330664888704; Email: mh.barba@ecten.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient, male or female, over the age of 18
• Patient with a primary and/or external iliac lesion (TASC A, B and C)
• Patient for whom unilateral angioplasty is indicated
• Affiliated patient or beneficiary of a social security scheme
• Patient having been informed and having signed a written consent.

Exclusion Criteria:

• Patient with a BMI strictly less than 18.5 or greater than or equal to 30.0 kg/m²
• Patient with long iliac thrombosis (including the primitive iliac and the external iliac)
• Patient with a known allergy to iodine
• Patient with a contraindication related to the procedure
• Patient for whom a bilateral iliac procedure is indicated
• Patient requiring an associated infra-inguinal endovascular procedure
• Patient participating in another clinical study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breastfeeding or parturient women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angioplasty DSA; Reference procedure (DSA), comprising: production of fluoroscopy images for placement of endoluminal material and navigation, subtracted angiography with placement of flaps to reduce the field of rays ("collimation ") for visualization of the arterial axis (in low dose, pulsed with maximum collimation), the realization of possible oblique incidences (external iliac), the catheterization with or without placement of a post-inflation stent, then the realization of a second subtracted control angiogram.	Procedure: Standard Angioplasty; Angioplasty Iliac done following standard practice
Experimental: Angioplasty DSA+Fusion; Procedure under study (DSA+Fusion), including: production of fluoroscopy images for placement of the endoluminal material and navigation, 2 fluoroscopy images specifically for image fusion registration (from the images scanner), selective angiography under fluoroscopy with collimation to improve registration (in low dose mode, pulsed with maximum collimation), if possible no oblique views (3D markers of the fusion), with or without placement of post-inflation stent followed by subtracted control angiography	Procedure: Angioplasty with D images; Angioplasty Iliac under additional 3D Images merged as surgery support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irradiation rate	mean irradiation rate during iliac angioplasty will be compared between the 2 study groups The primary endpoint of the research is the patient's intraoperative irradiation rate defined by measuring the dose area product (DAP) in Gy.cm2	"immedialtely at the end of surgery procedure"

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: irradiation patient rate; iliac angioplasty
• Other Study ID Numbers: 2020-A03414-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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