A safety study of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral berry aneurysms
| ISRCTN | ISRCTN36582296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36582296 |
| Secondary identifying numbers | Protocol No. VALOR 8002 |
- Submission date
- 08/09/2009
- Registration date
- 06/10/2009
- Last edited
- 11/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Joti Johnaton Bhattacharya
Scientific
Scientific
Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Study information
| Study design | Single-arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information materials are available at the investigational sites and by contacting Valor Medical (the trial sponsor) at info@valormedical.com |
| Scientific title | A prospective, non-randomised, open-label, multicenter safety study of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral berry aneurysms |
| Study objectives | The primary objectives of this safety study are to assess the efficacy and composite safety-and-efficacy of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral aneurysms. The secondary objectives assess other features of the treatment, including the incidence of all AEs, an assessment of the passage of unwanted device into the arterial lumen, the user acceptability of the device, the success of delivery, need for retreatment, and neurologic deterioration. |
| Ethics approval(s) | 1. Germany: Medical Faculty of the University Duisberg, Essen Ethics Committee, approved on 05/05/2009 (ref: 09-4030) 2. United Kingdom: Scotland A Research Ethics Committee, approved on 05/08/2009 (ref: 09/MRE00/47) 3. Hungary: To be submitted as of 08/09/2009 |
| Health condition(s) or problem(s) studied | Berry aneurysms in the brain |
| Intervention | 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 visits at 6 weeks and at 5 months following hospital discharge. All hospital visits and all follow-up visits include neurological assessments and adverse events/serious adverse events (AE/SAE) collection. The 6-month visit includes brain imaging (computed tomography angiography [CTA], magnetic resonance imaging [MRI]) or catheter angiography to assess the aneurysm. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 <=25% of the arterial lumen iii. Device in brain arteries that compromise 26-50% of the arterial lumen iv. Device in brain arteries that compromise 51-75% of the arterial lumen v. 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. |
| Overall study start date | 01/09/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Germany
- Hungary
- Scotland
- United Kingdom
Study participating centre
Southern General Hospital
Glasgow
G51 4TF
United Kingdom
G51 4TF
United Kingdom
Sponsor information
Valor Medical Inc. (USA)
Industry
Industry
6749 Top Gun Street
Suite 109
San Diego, CA
92121
United States of America
| Phone | +1 (858) 643 1675 |
|---|---|
| info@valormedical.com | |
| Website | http://valormedical.com |
Funders
Funder type
Industry
Valor Medical Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/05/2017: No publications found in PubMed, verifying study status with principal investigator
