Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05353309 |
Other study ID # |
2020-A03414-35 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.