Condition category
Circulatory System
Date applied
02/02/2011
Date assigned
07/04/2011
Last edited
05/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 patient’s 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

Sponsor information

Organisation

Lothian University Hospitals Division (UK)

Sponsor details

NHS Lothian
Research and Development Office
Queen Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes

05/04/2016: Plain English summary added.