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:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT02863133
Eligibility Criteria:
Inclusion Criteria:
1. Subject is aged 18 years or over
2. Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment
3. Subject has provided written consent for the procedure.
4. Subject agrees to all follow up visits required by the protocol
5. The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
Exclusion Criteria:
1. The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization.
2. The subject has had acute cerebral bleeding within the last 6 months.
3. The patient is participating in another research study involving another investigational device, procedure or drug.
4. The brain AVM or DAVF or tumor has been previously treated with another embolization agent.
5. The subject has a bleeding disorder.
6. The subject is female and has a positive pregnancy test.
7. The subject has a life expectancy of less than 1 year.
8. Subject has a known allergy to contrast media used for radiography.
9. Subject has a known allergy to Dimethyl Sulfoxide - DMSO (solvent for the embolic product).
10. Subject has a condition that would prevent them attending follow up visits for up to 1 year.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02863133
Study Brief:
Protocol Section:
NCT02863133