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

NCT05353309 | Unknown

• 1 other identifier: 2020-A03414-35
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Irradiation Rate; Image, Body; Iliac Artery Disease

Keywords

irradiation patient rate; iliac angioplasty

Outcome Measures

Primary Outcomes (1)

• 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"

Study Arms (2)

Angioplasty DSA

ACTIVE COMPARATOR

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.

Procedure: Standard Angioplasty

Angioplasty DSA+Fusion

EXPERIMENTAL

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

Procedure: Angioplasty with D images

Interventions

Standard Angioplasty PROCEDURE

Angioplasty Iliac done following standard practice

Angioplasty DSA

Angioplasty with D images PROCEDURE

Angioplasty Iliac under additional 3D Images merged as surgery support

Angioplasty DSA+Fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (2)

CHU de Nantes

Nantes, Brittany Region, 44093, France

RECRUITING

Saint Martin Private Hospital

Caen, Normandy, 14050, France

RECRUITING

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

JF ECTEN

CONTACT

0683346567; jf.oudet@ecten.eu

MH BARBA

CONTACT

0664888704; mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 29, 2022
• Study Start: May 25, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

FR (2)