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Can 3D image fusion make angioplasty safer by cutting radiation?

NCT ID NCT05353309

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This trial investigates whether using 3D image fusion during iliac angioplasty reduces the amount of radiation patients receive compared to standard practice. The study involves 37 adults with iliac artery narrowing who need angioplasty. Researchers will measure radiation exposure in both groups to see if the newer imaging technique is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If image fusion reduces radiation, it could make angioplasty safer for patients and staff.
What could go wrong
This is a small, early-stage study focused on radiation measurement, not clinical outcomes. The technique may not reduce radiation significantly or may have other drawbacks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

May 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, Brittany Region, 44093, France

  • Saint Martin Private Hospital

    Caen, Normandy, 14050, France

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