Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
NCT ID: NCT05353309
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2021-05-25
2023-09-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Angioplasty DSA
Reference procedure (DSA), comprising: production of fluoroscopy images for placement of endoluminal material and navigation, subtracted angiography with placement of flaps to reduce the field of rays ("collimation ") for visualization of the arterial axis (in low dose, pulsed with maximum collimation), the realization of possible oblique incidences (external iliac), the catheterization with or without placement of a post-inflation stent, then the realization of a second subtracted control angiogram.
Standard Angioplasty
Angioplasty Iliac done following standard practice
Angioplasty DSA+Fusion
Procedure under study (DSA+Fusion), including: production of fluoroscopy images for placement of the endoluminal material and navigation, 2 fluoroscopy images specifically for image fusion registration (from the images scanner), selective angiography under fluoroscopy with collimation to improve registration (in low dose mode, pulsed with maximum collimation), if possible no oblique views (3D markers of the fusion), with or without placement of post-inflation stent followed by subtracted control angiography
Angioplasty with D images
Angioplasty Iliac under additional 3D Images merged as surgery support
Interventions
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Standard Angioplasty
Angioplasty Iliac done following standard practice
Angioplasty with D images
Angioplasty Iliac under additional 3D Images merged as surgery support
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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CHU de Nantes
Nantes, Brittany Region, France
Saint Martin Private Hospital
Caen, Normandy, France
Countries
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Central Contacts
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Facility Contacts
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Blandine Maurel, Dr
Role: primary
Maximilien GIOVANNETTI, Dr
Role: primary
Marie Barba
Role: backup
Other Identifiers
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2020-A03414-35
Identifier Type: -
Identifier Source: org_study_id