Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT05355259
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥18 years old.
2. An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
3. Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
4. Subject is eligible to undergo a procedure with the use of contrast media.
5. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
6. Subject has given written informed consent.
7. Life expectancy \>12 months.
Exclusion Criteria:
1. Subject is unconscious and unable to directly provide his/her written informed consent.
2. Subject with a type 3 aortic arch will be excluded from the study.
3. Subject is or has been treated with radiation therapy to the neck or chest.
4. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
5. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
6. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
7. Subject is unable to complete the required follow-up.
8. Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
9. Subject has participated in a clinical study within the last 30 days.
10. Subject with cardiac pacemaker or defibrillator.
11. Persons under guardianship or curatorship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05355259
Study Brief:
Protocol Section:
NCT05355259