The Citadel Embolization Device Study

What is the Purpose of this Study?

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).


Eligibility

  • 1. Age is ≥18 and ≤80 years
  • 2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days.
  • 3. Aneurysm morphology is saccular
  • 4. Aneurysm size is between 6-12 mm
Show more

Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

The Citadel Embolization Device Study

Study Details
Disease Type/Condition

Other

Principal Investigator

Alexander, Michael

Age Group

Adult

Phase

I

IRB Number

STUDY00003444

ClinicalTrials.gov ID

NCT04057352

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Alexander, Michael

Age Group

Adult

Phase

I

IRB Number

CDM10001448

ClinicalTrials.gov ID

NCT04057352

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org