Comparison of iodinated contrast media injection protocols with reduced flow rates and volumes on image quality in diagnostic cerebral angiography for the evaluation of unruptured intracranial aneurysms: towards a standardization of practices (OPIAC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Les Hopitaux Universitaires De Strasbourg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-05-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Direction générale de l'offre de soins (DGOS) - PHRIP-24-0051

External identifiers

EU CT number

2025-524884-18-01

ClinicalTrials.gov

NCT07302646

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate the non-inferiority of reduced-rate and reduced-volume ICM injection protocols – selectively administered via internal carotid and vertebral artery catheterisation – compared to the standard protocol currently used in Strasbourg University Hospitals, in terms of image quality for the evaluation of unruptured intracranial aneurysms in cerebral angiography.

Secondary objectives 5

1. To evaluate and compare reproducibility in the assessment of exploitable/non-exploitable images between radiographers and interventional neuroradiologists;
2. To assess patient discomfort and satisfaction according to the different iodinated contrast media injection protocols used;
3. To evaluate the metrological properties of an innovative assessment grid, based on specific and formalised quality criteria, in the analysis of injection quality on angiographic images, compared with a traditional and more subjective analysis, classifying images as exploitable or non-exploitable
4. To analyse the economic and environmental impact of different iodinated contrast media injection protocols;
5. To evaluate the impact of different protocols on the examination time and the need for image repetition.

Conditions and MedDRA coding

Intracranial aneurysms

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult participant at the time of consent (age between 18 and 80 years old);
2. Scheduled diagnostic cerebral angiography as part of routine care: - Initial assessment of the IA (suspected or detected in non-invasive imaging); - Follow-up of one or more IAs (treated or untreated);
3. Conscious and oriented participant, able to undergo the procedure under simple local anaesthesia;
4. Participant able to understand the objectives of the research and provide a dated, signed informed consent form
5. Participant able to answer oral or written questions (French-speaking or understanding French)
6. For women of childbearing potential: negative serum β-HCG test at the inclusion visit
7. Participant covered by a social security health insurance plan.

Exclusion criteria 7

1. Emergency cerebral angiography
2. Participants with other neurovascular conditions (AVM, AVF, etc.) in addition to an IA
3. Participants with any contraindication to the use of Visipaque®
4. Pregnancy or breastfeeding
5. Participants whose physical or psychological condition requires sedation or general anaesthesia for the procedure
6. Participants with communication or cognitive disorders
7. Incapable participants (subject to legal protection measures: curatorship, guardianship, judicial protection, future protection mandate, family authorization).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Ratio of exploitable 2D and 3D images, assessed by radiographers, obtained with each injection protocol (reduced flow rates/standard volumes; reduced volumes/standard flow rates; reduced flow rates and volumes), compared to the standard/empirical protocol

Secondary endpoints 5

1. Accordance between radiographers’ assessment and interventional neuroradiologist evaluation regarding images classified as exploitable or non-exploitable, and inter- evaluator reproducibility (between radiographers, between neuroradiologists, and between radiographers and neuroradiologists);
2. Patient discomfort assessed orally by a radiographer or nurse in the theatre using a simple verbal scale (EVS, Échelle Verbale Simple, score 0-4) at the beginning of procedure (baseline) and after each injection/acquisition; Patient satisfaction assessed using a SAPS questionnaire, and inventory of side effects and their maximum intensity at the end of the examination
3. Description of the results obtained from a qualitative assessment grid and correlation with the quantitative results; Analysis of the predictive reliability of the grid in relation to images exploitability; Analysis of inter-evaluator reproducibility of the grid
4. Average ICM cost per protocol, depending on the number and type of vials used, and assessment of environmental impact (carbon footprint and waste management)
5. Average examination time per protocol, including injection/acquisition time and number of repetitions required to obtain exploitable results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Les Hopitaux Universitaires De Strasbourg

Sponsor organisation

Les Hopitaux Universitaires De Strasbourg

Address

1 Place De L Hopital, Cs 80426 Cs 80426

City

Strasbourg Cedex

Postcode

67091

Country

France

Scientific contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

HUSTACHE Sarah

Public contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

HUSTACHE Sarah

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications