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The purpose of this study is to evaluate the safety and effectiveness of the investigational Stryker Citadel Embolization Device for use in the treatment of patients with an aneurysm in the brain. A brain (cerebral) aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain.
This device is an investigational device that has not been approved by the U.S. Food & Drug Administration (FDA) for treatment of this type of aneurysm.
The device is used in a procedure called an endovascular aneurysm treatment because the device is delivered through the blood vessels. It is a specially designed metallic coil implant that is delivered through a small catheter (a long, flexible tube) that is inserted into the brain through a blood vessel in the leg (groin) or arm (wrist). One or more of the devices are then placed in the brain aneurysm by moving it through the catheter to create a basket (frame). Once the device(s) is/are placed inside the brain aneurysm, additional FDA-approved coils will be implanted to fill in the aneurysm to create a tissue mass that fills the aneurysm and stops the flow of blood into the aneurysm. The additional coils used are not investigational devices.
Total study participation is expected to last up to 15 months from the day of the procedure. This includes follow up appointments and phone call check-ins.
Inclusion criteria:
1. Between 18-80 years old
2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment.
Exclusion criteria:
1. Target aneurysm has been previously treated
2. Has had a recent (within 90 days) ischemic stroke, transient ischemic attack (TIA), or intracranial hemorrhage
Detailed eligibility will be reviewed when you contact the study team.
Upper East Side - Manhattan
Open to Enrollment
