Berry aneurysms in the brain Circulatory System Other cerebrovascular diseases
Conditions
Interventions
The treatment being studied is the Neucrylate AN™ Liquid Embolic System, which is a liquid that is placed into the aneurysm via angiography catheters. There is no comparator. There are follow-up visit
Sponsors
Valor Medical Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be a male or female >=18 years of age (i.e., not children as defined by local law or regulation) 2. Subject must have a cerebral aneurysm and neurological status 3. Subject must be considered by the physician to be available for subsequent visits 4. Subject must be able to comply with all aspects of the treatment and evaluation schedule over 7 months duration 5. Subject must sign and date an EC/IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures (if unable to sign for self, where applicable, legal representative may do so) 6. Subject has not previously been treated for aneurysm or subarachnoid haemorrhage
Exclusion criteria
Exclusion criteria: 1. Subject is female and pregnant, or breastfeeding 2. Subject has a known allergy to cyanoacrylates 3. Subject has a significant bleeding disorder 4. Subject has known hypersensitivity to any component of the study device or procedural materials 5. Subject is concurrently involved in another investigational study 6. Subject has received any investigational product within 30 days prior to entry into this trial 7. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial 8. Inability to obtain valid informed consent (consent may be given by legal representative, where applicable) 9. Subject has a life expectancy of less than 1 year due to other illness or condition (in addition to aneurysm) 10. The subject requires treatment for fusiform or lateral aneurysm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Neurological assessments will be done using the Glasgow Coma Scale, Hunt and Hess Scale, and Modified Rankin Score. These will be done at Screening, Procedure Day, Post-procedure Day 1, Hospital Discharge, Week 6, and at the Month 6 Visit. 2. Aneurysm filling will be assessed using the following scale on Procedure Day and at the Month 6 Visit: i. 0 - 24% filling ii. 25 - 49% filling iii. 50 - 74% filling iv. 75 - 89% filling v. 90% filling or more 3. Major Adverse Events (MAEs): During the implant procedure and for the 6-month follow-up period, all of the deaths, major strokes (resulting in a Modified Rankin score of >=3), and haemorrhages from the treated aneurysm will be documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse Events (AEs) and Serious Adverse Events (SAEs): During the implant procedure and for the 6-month follow-up period, all of the adverse events and serious adverse events will be documented. The investigator will provide his/her opinion, based on clinical experience and judgment, on the relationship between the event and either: (a) the procedure done to implant Neucrylate™, or (b) the presence of the Neucrylate™ in the body. 2. Unwanted device: Unwanted passage of device beyond the aneurysm in the parent vessel, or prior to reaching the aneurysm, on a 6-point scale: i. No device in brain arteries noted ii. Device in brain arteries that compromise =75% of the arterial lumen vi. Device completely occludes arterial lumen 3. User acceptability: For all three user acceptability measures (1) visibility of material, (2) ease of introduction, and (3) ease of delivery, assessments will be recorded. | — |
Countries
Germany, Hungary, United Kingdom
Outcome results
None listed