Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate

Not Applicable

• Conditions: Irradiation Rate; Image, Body; Iliac Artery Disease

• Registration Number: NCT05353309
• Lead Sponsor: Ramsay Générale de Santé

Brief 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.

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 Timeline

• Study Start: 2021-05-25
• Status Verified: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Irradiation rate	"immedialtely at the end of surgery procedure"	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

Trial Locations

Locations (2)

CHU de Nantes; 🇫🇷 Nantes, Bretagne, France

Saint Martin Private Hospital; 🇫🇷 Caen, Normandy, France