I67.1
Conditions
Interventions
Group 1: Endovascular coil embolisation with Hydrosoft coils
Group 2: Endovascular coil embolisation with bare platinum coils
Sponsors
Klinik für Neuroradiologie
Neurozentrum
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Aneurysm from 4 – 12 mm in diameter • Anatomy such that endovascular occlusion is deemed possible (not necessarily probable) • The neurointerventionist is content to use either bare platinum or HydroSoft depending on randomisation result • The neurointerventionalist is content not to use any other type of coated coil • The patient has not been previously randomised into this trial • Aneurysm has not previously been treated (by coiling or clipping).
Exclusion criteria
Exclusion 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 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 criterion. Use of coil assist devices (stent, balloon, trispan etc) should be recorded but is not an exclusion criterion. It must be recorded in order to ascertain if any difference in use between control & HydroCoil groups acts as a potential confounding variable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of major aneurysm recurrence on follow-up angiography and clinical outcome within 18 months (Formulation of endpoint amended for clarification; primary endpoint combining angiographic outcomes [major recurrence], re-treatment, and clinical outcomes in the absence of angiographic follow-up was specified before the trial started) | — |
Secondary
| Measure | Time frame |
|---|---|
| Packing density, Coil length deployed, Clinical outcome at 6 and 18 months post-coiling, as measured by modified Rankin scale | — |
Countries
France, Germany
Contacts
Public ContactChristian Taschner
Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
Outcome results
None listed