Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Dr Philip White


Contact details

Western General Hospital
Crewe Road
United Kingdom

Additional identifiers

EudraCT number 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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cerebrovascular - aneurysms


Aneurysm coiling +/- stent assistance

Intervention type



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

Germany, Korea, South, Netherlands, Sweden, United Kingdom, United States of America

Trial participating centre

Western General Hospital
United Kingdom

Sponsor information


Lothian University Hospitals Division (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

Microvention Terumo Inc. (United States of America)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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.