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Treatment Study of Wide-Neck Bifurcation Intracranial Aneurysm

Clinical Trial Title: 
NAPA: A prospective, multi-center, single arm study to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device used with endovascular coil embolization in the treatment of wide-neck bifurcation intracranial aneurysm.
Clinical Trial Protocol ID: 
17091803
Clinical Trial Investigator Name: 
Richard Webster Crowley, MD
Clinical Trial Protocol Description: 

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.

Clinical Trial Eligibility Criteria: 

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.

Clinical Trial Area: 
Stroke and Cerebrovascular Disease
Contact Phone: 
(312) 942-8681
Contact Name: 
Kevin Keegan