Plain English Summary
Background and study aims
An intracranial aneurysm is a bulge in a blood vessel in the brain, caused by a weakness in the vessel wall. If it bursts (ruptures) this leads to bleeding and brain damage. Preventative surgery is recommended if there is a high risk of a rupture. Endovascular coiling involves inserting a thin tube into the aneurysm and passing tiny metal coils into the aneurysm to seal it off, preventing it from growing or rupturing. The aim of this study is to find out whether inserting a self-expanding tube (stent) into the aneurysm to assist coiling improves the outcome for the patient.
Who can participate?
Patients aged 18-70 with an intracranial aneurysm
What does the study involve?
Participants are randomly allocated to be treated with coiling either with or without stent assistance. Participants are assessed by angiography (a type of x-ray used to examine blood vessels) 12 months later to check for aneurysm recurrence.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Western General Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2011 to June 2016
Who is funding the study?
Microvention Terumo Inc. (USA)
Who is the main contact?
Dr Philip White
pmw@skull.dcn.ed.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Philip White
ORCID ID
Contact details
DCN X-Ray
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
-
pmw@skull.dcn.ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3/08/2010
Study information
Scientific title
Treatment of Intracranial Aneurysms using a vascular Reconstruction Assist device: a randomised controlled trial of self expanding stent (conventional mesh density) plus coiling versus coiling +/- temporary assist techniques
Acronym
TIARA
Study hypothesis
Use of self-expanding stent will not improve angiographic outcome at 12 months (as assessed by independent core laboratory)
Ethics approval
Ethics approval pending from UK Integrated Research Application System (IRAS). All other centres will seek ethics approval before recruitment of the first participant.
Study design
Prospective multinational randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cerebrovascular - aneurysms
Intervention
Aneurysm coiling +/- stent assistance
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Major angiographic recurrence rate at 12 months post procedure
Secondary outcome measures
1. Procedural outcomes (procedural morbidity & mortality)
2. Clinical outcomes: Modified Rankin Scale (MRS) at discharge, 90 days and 1 year
3. Re-bleed & retreatment rates at 1 year (and to end of trial follow-up)
4. Non target aneurysm bleeding events resulting in hospitalisation or other serious adverse event ( AE) within 30/7 of target procedure resulting in hospitalisation
Overall trial start date
01/06/2011
Overall trial end date
01/06/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age range 18-70 (evidence that procedural risk for stent placement in over 70 is 4 fold greater and saccular aneurysms are extremely uncommon under 18)
2. Patient world federation of neurosurgeons (WFNS) Grade 0-2 [anticipated most patients recruited will be 0]
3. Aneurysm judged suitable for treatment by coiling plus or minus the stent assistance and operator content to use/not use stent according to randomisation treatment allocation result
4. Aneurysm greater than or equal to 8mm in maximal diameter, with aneurysm neck greater than 4mm or dome to neck ratio less than 2:1, but less than 25mm in size. If target aneurysm previously treated by coiling the recurrence must have a maximal diameter in this range
5. If a patient presents with subarachnoid haemorrhage (SAH) and staged treatment with delayed stenting is judged appropriate due to aneurysm size/neck width then the patient is eligible
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
550
Participant exclusion criteria
1. Does not meet aneurysm size/neck characteristics outlined in inclusion criteria
2. Less than18 years or more than 70 years of age
3. Pregnant
4. Unable to consent for themselves
5. Non-saccular aneurysm - e.g. blister, fusiform or definitely dissecting aneurysm
6. Subarachnoid hemorrhage (SAH)/intracerebral haemorrhage from another aneurysm or intracranial lesion within last 28 days
7. Major surgery within last 30 days (or any other medical situation where dual antiplatelet therapy is contraindicated in the opinion of the responsible neurovascular team)
8. Intention to deploy flow diverting device/construct as primary aneurysm treatment
9. More than one aneurysm requiring treatment in current procedure
10. Target or a nearby aneurysm has had previous stent treatment such that a Vascular Reconstruction Device [VRD i.e. a stent] is already across all or greater than 1/3 of the neck of the target aneurysm
11. Medical or surgical co-morbidity such that the patients life expectancy is less than 1 year
12. The patient has been previously randomised into this trial
13. Patient has been randomised into another trial of an endovascular device for aneurysm treatment within the last 6 months
14. Deployment of stent judged essential to treat the aneurysm
Recruitment start date
01/06/2011
Recruitment end date
01/06/2016
Locations
Countries of recruitment
Germany, Korea, South, Netherlands, Sweden, United Kingdom, United States of America
Trial participating centre
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Funders
Funder type
Industry
Funder name
Microvention Terumo Inc. (United States of America)
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