Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol No. VALOR 8002
Study information
Scientific title
A prospective, non-randomised, open-label, multicenter safety study of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral berry aneurysms
Acronym
Study hypothesis
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
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
Study design
Single-arm interventional study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information materials are available at the investigational sites and by contacting Valor Medical (the trial sponsor) at info@valormedical.com
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Germany, Hungary, United Kingdom
Trial participating centre
Southern General Hospital
Glasgow
G51 4TF
United Kingdom
Sponsor information
Organisation
Valor Medical Inc. (USA)
Sponsor details
6749 Top Gun Street
Suite 109
San Diego
CA
92121
United States of America
+1 (858) 643 1675
info@valormedical.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Valor Medical Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list