Irradiation RateAIFITINCT05353309
Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
A study testing Standard Angioplasty and Angioplasty with D images in people with Irradiation Rate and Image, Body, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irradiation Rate, Image, Body, Iliac Artery Disease
- What is being tested?
- Standard Angioplasty and Angioplasty with D images
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- 25 May 2021to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Saint Martin Private Hospital
Caen, Normandy, 14050
CHU de Nantes
Nantes, Brittany Region, 44093
About this study
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.
Read the 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
- Being tested
- Standard Angioplasty, Angioplasty with D images
- Keywords
- irradiation patient rate, iliac angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard AngioplastyProcedure or surgery
Angioplasty Iliac done following standard practice
Angioplasty with D imagesProcedure or surgery
Angioplasty Iliac under additional 3D Images merged as surgery support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Angioplasty with D images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "immedialtely at the end of surgery procedure"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start25 May 2021
- Primary completion10 Jul 2024
- Study completion10 Dec 2024
Why it stopped: Recrutment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irradiation RateStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353309
- Sponsor's protocol ID
- 2020-A03414-35
- Acronym
- AIFITI
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
- ClinicalTrials.gov ID
- NCT05353309
- Acronym / sponsor ID
- AIFITI / 2020-A03414-35
- Conditions
- Irradiation Rate, Image, Body, Iliac Artery Disease
- Keywords
- irradiation patient rate, iliac angioplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recrutment difficulties
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 25 May 2021 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angioplasty DSA | Active comparator | Procedure: Standard AngioplastyReference 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. |
| Angioplasty DSA+Fusion | Experimental | Procedure: Angioplasty with D imagesProcedure 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard AngioplastyAngioplasty Iliac done following standard practice | Procedure or surgery | Angioplasty DSA |
| Angioplasty with D imagesAngioplasty Iliac under additional 3D Images merged as surgery support | Procedure or surgery | Angioplasty DSA+Fusion |
Primary outcome
Irradiation rate
Time frame: "immedialtely at the end of surgery procedure"
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
Results and safety
The study was stopped early (reason given: Recrutment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Angioplasty and Angioplasty with D images in people with Irradiation Rate and Image, Body, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recrutment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irradiation rate (time frame: "immedialtely at the end of surgery procedure"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.