Condition category
Circulatory System
Date applied
08/09/2009
Date assigned
06/10/2009
Last edited
29/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joti Johnaton Bhattacharya

ORCID ID

Contact details

Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

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 measures

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

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

http://valormedical.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes