Clinical trial NCT05353309: Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
Official title: Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irradiation Rate
Image, Body
Iliac Artery Disease
Keywords: irradiation patient rate
iliac angioplasty
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-04-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Irradiation rate
timeFrame: "immedialtely at the end of surgery procedure"
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Bretagne
city: Caen
country: France
facility: Saint Martin Private Hospital
state: Normandy
Study officials:
References: