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

Image, Body Clinical Trial

— AIFITI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353309
• Other study ID #: 2020-A03414-35
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2022
• Source: Ramsay Générale de Santé
• Contact: JF ECTEN
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iliac Artery Disease
• Image, Body

Intervention

Procedure:
• Standard Angioplasty
Angioplasty Iliac done following standard practice
• Angioplasty with D images
Angioplasty Iliac under additional 3D Images merged as surgery support

Locations

Country	Name	City	State
France	Saint Martin Private Hospital	Caen	Normandy
France	CHU de Nantes	Nantes	Bretagne

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"