Cerebral Aneurysms Clinical Trial
Official title:
Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.
Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates
of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we
will compare recanalization or recurrence rates observed in this prospective registry of
HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare
platinum coils. This registry is designed to achieve 80% power to detect a minimally
clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms
compared with bare platinum coils. Based on recent, prospective, randomized trials assessing
both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates,
respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically,
a "minimally clinically relevant difference" is on the order of a 30% diminution in a given
undesirable outcome. As such, the registry is well powered to detect this minimally
clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils
versus 25% for the historical control group).
Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be
placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
Success of this aim is defined as ease of placement of the HydroSoft device, without need for
coil removal and subsequent "finishing" with a bare platinum coil.
Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is
associated with risks of thromboembolism similar to that with other coil types, on the order
of 3-5% or less.
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