NCT05353309

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irradiation Rate
• Image, Body
• Iliac Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Standard Angioplasty	Angioplasty Iliac done following standard practice
PROCEDURE	Angioplasty with D images	Angioplasty Iliac under additional 3D Images merged as surgery support

Timeline

• Start date: 2021-05-25
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

2 sites across 1 country: France