Hydrocoil: Endovascular Aneurysm Occlusion and Packing Study

Completed

• Conditions: Intracranial aneurysms; Circulatory System; Aneurysm

• Registration Number: ISRCTN30531382
• Lead Sponsor: othian University Hospitals Division (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patient presenting with a cerebral aneurysm deemed to require endovascular treatment by the neurosurgeon/neurointerventionist (generically referred to subsequently as 'the neurovascular team'), and:
1. Patient has given fully informed consent to endovascular coiling procedure
2. Aneurysm 2 - 25 mm in maximum diameter
3. Anatomy such that endovascular occlusion is deemed possible (not necessarily probable)
4. The neurointerventionist is content to use either bare platinum or hydrocoil embolic system (HES) depending on randomisation result (i.e., clinical equipoise principle applies)
5. The neurointerventionist is content not to use any other type of coated coil
6. Patient World Federation of Neurological Surgeons (WFNS) Grade 0 - 2 and aged 18 - 75 years
7. The patient has not been previously randomised into this trial
8. Aneurysm has not previously been treated (by coiling or clipping)

Exclusion Criteria

Subjects will not be considered for the trial unless they meet all the inclusion criteria. If the patient has more than one aneurysm requiring treatment at the same treatment episode they will not be eligible for the trial. If treatment will be staged in a patient with multiple aneurysms and only one aneurysm will be treated at one sitting then the patient is eligible. However, a patient may not be randomised into the study more than once.

From the moment of randomisation, the patient is in the trial whether they receive trial treatment or not, and will be followed up and accounted for in the final analysis (intention-to-treat).

Death or procedural/disease related morbidity may result in some subjects not having check angiography (or magnetic resonance angiography [MRA] if unit uses this as standard mode of follow-up). These patients will be counted as poor outcomes in the primary analysis.

Retreatment of previously coiled or clipped aneurysm is an exclusion criteria.

Use of coil assist devices (stent, balloon, trispan etc.) should be recorded but is not an exclusion criteria. It must be recorded in order to ascertain if any difference in use between control and hydrocoil groups acts as a potential confounding variable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Angiographic outcomes at 15-18 months between aneurysms coiled using bare platinum coils (control group) and those coiled using hydrocoil embolic system.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures include packing density, clinical outcome, rebleed and retreatment comparisons between these 2 groups.