HydroCoil Cerebral Aneurysm Treatment Trial

Study Overview
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Brief Summary
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The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.

Detailed Description
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With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.

Official Title
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HydroCoil Cerebral Aneurysm Treatment Trial

Conditions
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Intracerebral Aneursym

Intervention / Treatment
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* Device: MicroVention Hydrogel coil
* Device: Non-hydrogel coils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist) The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel. Patients between (and including) 21 and 90 years of age. Patient HUNT AND HESS Grade 0-3. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney. Aneurysm 5-20mm in maximum diameter. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment. The patient has not been previously randomized into this or another related ongoing trial. The aneurysm has not previously been treated (by coiling or clipping). Exclusion Criteria: Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses). Target aneurysm has had previous coil treatment or surgically clipped. Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH). Inability to obtain informed consent. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MicroVention Hydrogel Coils<br>FDA approved and in common use for cerebral aneurysm treatment. | Device: MicroVention Hydrogel coil<br>* Micro Vention Hydrogel Coils<br>|
| Active Comparator: Non-hydrogel coils<br>Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm). | Device: Non-hydrogel coils<br>* Cerecyte or bare platinum coils<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate | Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment. | 12 - 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related morbidity and mortality | Treatment related morbidity and mortality, as measured by the NIH stroke scale; | 12-18 months | 
| Packing density | Packing density as measured by volumetric filling of the aneurysm. | 12-18 months | 
| Clinical outcome | Clinical outcome as measured by Modified Rankin Scale | 6 months | 
| Clinical Outcome | Clinical outcome as measured by the Modified Rankin scale | 12-18 months | 
| Re-bleed rates | Comparison of rebleed rates at 12-18 months | 12-18 months | 
| Re-treatment rates | Comparison of re-treatment rates at 12-18 months post treatment. | 12-18 months | 
| Cost of treatment | Comparison of cost of treatment. | 12-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, cerebral aneursym, neurology, radiology