Intracranial aneurysms both ruptured and unruptured collectively affect a significant portion
of the general population. Cases of unruptured intracranial aneurysms (UIA) are estimated to
affect roughly 3% of the general population and aneurysmal subarachnoid hemorrhage (aSAH) has
an incidence of 8 to 9 people per 100,000. There are two well-established treatment options
for patients diagnosed with intracranial aneurysms (IA): surgical clipping and endovascular
coiling. Neurosurgical intervention requires a craniotomy followed by the clipping of the
aneurysm. Endovascular repair is minimally invasive as access to the afflicted vessel is
gained through the femoral artery with the assistance of imaging guidance. During
embolization, the aneurysm is occluded using coils of varying length, diameter, and softness.
By filling the dome of the aneurysm physicians aim to prevent further blood flow into the
bulge which will prevent the aneurysm from rupturing. In addition to coiling a stent may be
placed to function as a blood flow diverting device.
The first-ever recorded use of coils in the treatment of intracranial aneurysms by way of
endovascular intervention was in 1988. In 1989, detachable coils were designed by Guido
Guglielmi, an endovascular neurosurgeon, who pioneered the concept of coil embolization.
Since then, endovascular embolization has become effective, and in some cases preferred,
method of treatment of intracranial aneurysms. A 2005 randomized, multicenter study titled
International Subarachnoid Aneurysm Trial (ISAT) demonstrated that in comparison to surgical
clipping, endovascular repair clinical outcomes result in significant risk reduction and
long-term independence post-procedure. To verify their findings the ISAT authors reviewed the
clinical outcomes at 1 year of 1063 of 1072 patients who underwent ruptured aneurysm
embolization using detachable coils compared to 1055 of 1070 who were designated to
neurosurgical clipping. At the one-year mark patients who experienced endovascular repair
demonstrated poor prognosis with less frequency, as measured by mortality and extent of
dependency, in 23.5% of cases in comparison to 30.9% of subjects treated via neurosurgical
intervention. While the results seem to show a considerable preference for embolization, the
patients in this designated sample were found to experience rebleeds at a higher frequency.
Beyond resurgence of hemorrhaging, embolization risks include aneurysm perforation and/or
rupture, thromboembolic events, and coil herniation out of the occluded site. Despite the
aforementioned risk factors, it has become clear that embolization with detachable coils is a
much safer treatment option as the rate of procedure-related complications is relatively low.
This is true for patients with unruptured and ruptured intracranial aneurysms-size and
location did not show any statistically significant impact.
The study will enroll approximately 30 subjects to allow us to adequately observe the
benefits of the central limit theorem. Based on prior experience, we expect that
approximately 10% of all participants may be lost to follow-up and/or will withdraw from the
study. It is estimated that two years are needed to complete the study. The first year will
be necessary to enroll 30 subjects and the second year will be necessary to complete the
12-month follow-up visits and study close out procedures. The device is to be used per
Instructions for Use as indicated for treatment of intracranial aneurysms by way of coil
embolization. Participating in this study will not contribute or be of detriment in any way
of a subject's medical care. All study related data gathering activities are standard of care
and do not require any special actions.