Treatment of Intracranial Aneurysms using vascular Reconstruction Assist device

Completed

• Conditions: Cerebrovascular - aneurysms; Circulatory System; Cerebrovascular diseases

• Registration Number: ISRCTN13532658
• Lead Sponsor: othian University Hospitals Division (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-07
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 550

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major angiographic recurrence rate at 12 months post procedure

Secondary Outcome Measures

Name	Time	Method
1. Procedural outcomes (procedural morbidity & mortality) <br>2. Clinical outcomes: Modified Rankin Scale (MRS) at discharge, 90 days and 1 year<br>3. Re-bleed & retreatment rates at 1 year (and to end of trial follow-up)<br>4. Non target aneurysm bleeding events resulting in hospitalisation or other serious adverse event ( AE) within 30/7 of target procedure resulting in hospitalisation