Cerebral Aneurysm Clinical Trial
Official title:
New Generation Hydrogel Endovascular Aneurysm Treatment Trial
This research study is being done to test the effectiveness of a new generation FDA approved
device for treating aneurysms compared to the current standard device for endovascular
aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of
minimally invasive surgery, which is performed on blood vessels. The technique involves the
introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the
skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found
near the groin. The catheter is then maneuvered through the body to the location of the
aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the
catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter.
This is repeated until enough coils fill the aneurysm, blocking the blood flow to the
aneurysm. The body responds by forming blood clots around the coil(s), which helps block the
flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study
will compare the study device to the standard bare platinum coil to see which is better at
preventing future rupturing or leaking. The study device is called the HydroCoil Embolization
System and this study is a post-market clinical trial.
About 600 subjects from multiple institutions will take part in this study.
Your part in this study will last up to 24 months and will involve 6 visits (1 baseline visit
before your surgery, the surgical procedure and 4 follow-up visits). These visits will occur
at the same time as the visits you would receive as standard of care after your surgery.
If you are in this study, you will be placed in one of two study groups by chance using a
process similar to the flip of a coin. This process is called randomization. Neither you nor
the study staff will select the group you will be in. One group, the control group, will have
their aneurysm treated by the bare platinum coils during their endovascular procedure. The
other group, the study group will receive coils from the HydroCoil Embolization System. Both
groups will receive the same standard of care and follow-up, but during the surgery different
types of coils will be used.
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