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Search / Trial NCT04578808

Unruptured Cerebral Aneurysm: Prediction of Evolution

Launched by NANTES UNIVERSITY HOSPITAL · Oct 1, 2020

Trial Information

Current as of August 26, 2025

Recruiting

Keywords

Unruptured Cerebral Aneurysm Aneurysm Prediction Growth Unruptured Intracranial Aneurysm

ClinConnect Summary

This clinical trial is focused on understanding unruptured intracranial aneurysms (UIAs), which are bulges in blood vessels in the brain that have not yet burst. The researchers aim to gather a large group of patients with these aneurysms to study how they might change over time and to explore potential new ways to evaluate and treat them. This study will involve detailed imaging tests, like MRI scans, and will follow participants for three years to collect important health information.

To be eligible for this trial, participants should be over 18 years old and have a specific type of unruptured aneurysm that measures between 3 and 7 mm. They should not have any serious health issues that would prevent them from undergoing MRI scans or using contrast dyes during imaging. Those who participate can expect regular check-ups and tests to monitor their aneurysm and help researchers learn more about how these conditions develop. It's a chance to contribute to important research that could improve future treatments for others with similar conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria :
  • Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter.
  • Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering.
  • Age \> 18 years old.
  • Exclusion Criteria :
  • A failure to obtain informed consent
  • Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia)
  • Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding)
  • A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation
  • A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease
  • Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)

About Nantes University Hospital

Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.

Locations

Brest, , France

Angers, Maine Et Loire, France

Nantes, Loire Atlantique, France

Marseille, Bouches Du Rhône, France

Brest, Finistère, France

Bordeaux, Gironde, France

Toulouse, Haute Garonne, France

Limoges, Haute Vienne, France

Paris, Ile De France, France

Rennes, Ille Et Vilaine, France

Tours, Indre Et Loire, France

Reims, Marne, France

Nancy, Meurthe Et Moselle, France

Rouen, Seine Maritime, France

Amiens, Somme, France

Créteil, Val De Marne, France

Paris, , France

Paris, , France

Paris, , France

Utrecht, , Netherlands

Bern, , Switzerland

Marseille, , France

Patients applied

0 patients applied

Trial Officials

Romain BOURCIER, MD

Principal Investigator

Nantes University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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