The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the Stryker Citadel Embolization Device for treating people with a brain aneurysm. A brain aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. Patients who have an unruptured or ruptured brain aneurysm will be enrolled in this study. The Stryker Citadel Embolization Device is used in a procedure called an endovascular aneurysm treatment. The device is a specially designed metallic coil implant that is delivered through a small catheter (a long, flexible tube) and inserted into the brain through a blood vessel in the leg (groin) or arm (wrist). One or more of the study devices is placed in the patient’s brain aneurysm by moving it through the catheter to create a basket (frame). Additional coils are then implanted to create a tissue mass that fills the aneurysm and stops the flow of blood into the aneurysm. The additional coils to be used are commercially available devices (approved by the U.S. Food and Drug Administration).
What is the full name of this clinical trial?
The Citadel Embolization Device Study