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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    350
  • sponsor
    Ramsay Générale de Santé
Updated on 12 May 2022

Summary

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.

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.

Details
Condition Irradiation Rate, Image, Body, Iliac Artery Disease
Treatment Standard Angioplasty, Angioplasty with D images
Clinical Study IdentifierNCT05353309
SponsorRamsay Générale de Santé
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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