Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate (NCT05353309) | Clinical Trial Compass
TerminatedNot Applicable
Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
Stopped: Recrutment difficulties
France37 participantsStarted 2021-05-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Irradiation rate
Timeframe: "immedialtely at the end of surgery procedure"
Trial details
NCT IDNCT05353309
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche