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Treatment Study of Wide-Neck Bifurcation Intracranial Aneurysm
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device. The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.
In order to participate you must meet the following criteria:
- Have wide neck intracranial aneurysm located at a bifurcation.
- Are between 18 and 80 years of age the time of consent.
- Have given informed consent and signed the IRB approved consent prior to beginning any study procedures.
- Placement of the PulseRider® device is technically feasible and clinically indicated.
You will be excluded from the study if any of the following criteria apply to you:
- Have unstable neurological deficit (condition worsening within the last 90 days).
- Have had subarachnoid hemorrhage (SAH) within the last 60 days.
- Have irreversible bleeding disorder.
- Has another intracranial aneurysm that in the investigator's opinion, may require treatment within the 1 year follow up period.
This is a partial list of inclusion and exclusion criteria.